Myocardial InfarctionPhase 3PEGASUSNCT01225562

Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin

A Phase 3 study testing Ticagrelor 90 mg and Ticagrelor 60 mg in people with Myocardial Infarction and Cardiovascular Death, run by AstraZeneca at 826 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke). Read more about this study

Who is it for?: Ages 50 to 130 years
Conditions the study is for: Myocardial Infarction, Cardiovascular Death, Atherothrombosis
What is being tested?: Ticagrelor 90 mg and Ticagrelor 60 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21,379 participants
Where: 826 sitesin 31 countries
Study dates: Oct 2010to Dec 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
Females of child-bearing potential must have a negative pregnancy test at enrollment
Persons who are currently taking aspirin between 75 and 150 mg once daily

Who cannot join

Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
Persons with known bleeding disorders
Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
Persons with a history of ischemic stroke
Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.

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Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
Persons with known severe liver disease
Persons with kidney failure requiring dialysis
Persons with life expectancy < 1 year

Trial locations and contacts

826 sites in 31 countries.

Country

City, postcode or hospital

826 sites in 31 countries

United States250 sites

Research Site
Akron, Ohio
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Albuquerque, New Mexico
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Alexander City, Alabama
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Alexandria, Louisiana
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Alexandria, Virginia
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Alhambra, California
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Alpena, Michigan
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Altoona, Pennsylvania
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Anaheim, California
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Anderson, South Carolina
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Ann Arbor, Michigan
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Asheville, North Carolina
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Athens, Alabama
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Atlanta, Georgia
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Auburn, Maine
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Augusta, Georgia
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Aurora, Colorado
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Aurora, Illinois
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Austin, Texas
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Avon, Indiana
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Ayer, Massachusetts
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Bakersfield, California
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Baltimore, Maryland
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Bangor, Maine
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Bannockburn, Illinois
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Baxter, Minnesota
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Beaver, Pennsylvania
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Bellevue, Washington
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Bend, Oregon
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Bethlehem, Pennsylvania
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Biddeford, Maine
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Billings, Montana
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Biloxi, Mississippi
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Birmingham, Alabama
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Boca Raton, Florida
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Boise, Idaho
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Boston, Massachusetts
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Bridgewater, New Jersey
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Buffalo, New York
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Burlington, Massachusetts
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Burlington, North Carolina
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Burlington, Vermont
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Canton, Ohio
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Cary, North Carolina
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Chambersburg, Pennsylvania
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Charleston, South Carolina
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Charlottesville, Virginia
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbia, Maryland
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Columbia, Missouri
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Columbus, Ohio
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Coral Springs, Florida
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Cortlandt Manor, New York
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Covington, Louisiana
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Crestview Hills, Kentucky
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Crystal River, Florida
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Cumming, Georgia
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Dallas, Texas
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Danville, Virginia
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Davie, Florida
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Dayton, Ohio
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Daytona Beach, Florida
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Detroit, Michigan
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Doylestown, Pennsylvania
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Duluth, Minnesota
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Elizabeth, New Jersey
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Elkhart, Indiana
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Elmer, New Jersey
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Erie, Pennsylvania
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Everett, Washington
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Fairfield, Ohio
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Falls Church, Virginia
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Flint, Michigan
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Florence, South Carolina
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Fort Lauderdale, Florida
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Fort Wayne, Indiana
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Fort Worth, Texas
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Fountain Valley, California
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Franklin, Indiana
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Gainesville, Florida
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Georgetown, Texas
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Germantown, Tennessee
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Glendale, Arizona
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Grand Blanc, Michigan
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Grand Forks, North Dakota
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Grand Rapids, Michigan
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Grapevine, Texas
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Great Falls, Montana
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Green Bay, Wisconsin
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Greensboro, North Carolina
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Greenville, South Carolina
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Haddon Heights, New Jersey
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Hartford, Connecticut
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Haverhill, Massachusetts
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Hialeah, Florida
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Hickory, North Carolina
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Hollywood, Florida
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Honolulu, Hawaii
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Houston, Texas
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Huntsville, Alabama
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Hutchinson, Kansas
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Indianapolis, Indiana
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Iowa City, Iowa
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Jackson, Michigan
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Jackson, Tennessee
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Jacksonville, Florida
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Johnstown, Pennsylvania
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Jonesboro, Arkansas
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Jupiter, Florida
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Kalispell, Montana
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Kansas City, Missouri
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Katy, Texas
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Kingwood, Texas
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Knoxville, Tennessee
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La Mesa, California
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Lancaster, Pennsylvania
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Langhorne, Pennsylvania
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Lapeer, Michigan
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Largo, Florida
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Larkspur, California
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Leesburg, Florida
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Lexington, Kentucky
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Lincoln, Nebraska
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Linden, New Jersey
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Little Rock, Arkansas
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Littleton, Colorado
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Lomita, California
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Los Angeles, California
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Louisville, Kentucky
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Loveland, Colorado
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Lynchburg, Virginia
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Manassas, Virginia
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Mansfield, Ohio
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Marquette, Michigan
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McAllen, Texas
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Melrose Park, Illinois
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Miami, Florida
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Miami Beach, Florida
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Minden, Louisiana
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Mine Hill, New Jersey
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Mineola, New York
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Minneapolis, Minnesota
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Mobile, Alabama
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Modesto, California
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Morganton, North Carolina
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Muncie, Indiana
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Munster, Indiana
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Naples, Florida
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Nashville, Tennessee
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New Iberia, Louisiana
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New Windsor, New York
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Newark, Delaware
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Newark, New Jersey
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Newport Beach, California
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Norfolk, Virginia
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Normal, Illinois
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North Dartmouth, Massachusetts
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Oak Ridge, Tennessee
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Oakland, California
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Ocala, Florida
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Oceanside, California
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Opelousas, Louisiana
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Orlando, Florida
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Oxon Hill, Maryland
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Pannama City, Florida
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Papillion, Nebraska
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Pensacola, Florida
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Petoskey, Michigan
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pinehurst, North Carolina
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Pittsburgh, Pennsylvania
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Plano, Texas
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Pontiac, Michigan
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Port Charlotte, Florida
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Portland, Oregon
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Poughkeepsie, New York
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Providence, Rhode Island
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Provo, Utah
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Raleigh, North Carolina
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Rapid City, South Dakota
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Reno, Nevada
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Richmond, Virginia
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Ridgewood, New Jersey
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Robbinsdale, Minnesota
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Rock Island, Illinois
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Rocky Mount, North Carolina
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Round Rock, Texas
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Safety Harbor, Florida
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Saginaw, Michigan
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Saint Cloud, Minnesota
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Salisbury, Maryland
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San Antonio, Texas
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San Diego, California
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San Marino, California
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Sandusky, Ohio
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Sanford, North Carolina
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Santa Rosa, California
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Sarasota, Florida
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Saratoga Springs, New York
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Scranton, Pennsylvania
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Sellersville, Pennsylvania
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Sheffield, Alabama
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Shreveport, Louisiana
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Slidell, Louisiana
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Smithfield, North Carolina
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Somerset, New Jersey
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South Miami, Florida
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South Portland, Maine
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Southampton, New York
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Southfield, Michigan
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Spokane, Washington
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Springfield, Ohio
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St Louis, Missouri
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St. Petersburg, Florida
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Stamford, Connecticut
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Statesville, North Carolina
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Stony Brook, New York
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Tacoma, Washington
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Tallahassee, Florida
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The Bronx, New York
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The Villages, Florida
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Toledo, Ohio
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Tomball, Texas
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Tullahoma, Tennessee
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Tulsa, Oklahoma
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Tupelo, Mississippi
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Tyler, Texas
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Ventura, California
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Victoria, Texas
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Washington D.C., District of Columbia
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Watertown, South Dakota
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Wausau, Wisconsin
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Wellington, Florida
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West Chester, Pennsylvania
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West Palm Beach, Florida
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Westlake Village, California
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Williamsville, New York
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Wilmington, North Carolina
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Winchester, Virginia
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York, Pennsylvania
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Youngstown, Ohio
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Ypsilanti, Michigan
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Zanesville, Ohio

Other trials in United States

Japan50 sites

Research Site
Akishima-shi
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Amagasaki-shi
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Beppu-shi
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Chūōku
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Daito-shi
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Fukui-shi
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Funabashi-shi
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Gifu
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Hamamatsu
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Himeji-shi
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Imabari
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Isehara-shi
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Kamogawa-shi
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Kanazawa
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Kawachinagano-shi
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Kisarazu-shi
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Komatsushima-shi
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Koriyama-shi
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Kumamoto
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Kure-shi
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Kusatsu-shi
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Kyoto
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Maebashi
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Matsue
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Matsumoto-shi
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Matsuyama
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Meguro-ku
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Miyazaki
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Osaka
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Saga
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Sagamihara-shi
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Saitama-shi
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Sakaide-shi
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Sakaishi
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Sapporo
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Sayama-shi
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Shimada-shi
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Shinagawa-ku
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Shizuoka
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Suwa-shi
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Takarazuka-shi
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Takasaki-shi
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Takatsuki-shi
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Tomakomai-shi
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Toyonaka-shi
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Ueda-shi
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Wakayama
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Wako-shi
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Yatsushiro-shi
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Yokohama

Other trials in Japan

Canada45 sites

Research Site
Brampton, Ontario
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Burlington, Ontario
Research Site
Cambridge, Ontario
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Chicoutimi, Quebec
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Cornwall, Ontario
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Edmonton, Alberta
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Gatineau, Quebec
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Greater Sudbury, Ontario
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Greenfield Park, Quebec
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Halifax, Nova Scotia
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Hamilton, Ontario
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Kelowna, British Columbia
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Kitchener, Ontario
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Laval, Quebec
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Lévis, Quebec
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London, Ontario
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Longueuil, Quebec
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Mississauga, Ontario
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Moncton, New Brunswick
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Montreal, Quebec
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New Westminster, British Columbia
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Newmarket, Ontario
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North York, Ontario
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Oshawa, Ontario
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Ottawa, Ontario
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Penticton, British Columbia
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Québec, Quebec
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Saint John, New Brunswick
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Saint-Charles-Borromée, Quebec
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Saint-Georges, Quebec
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Saint-Jérôme, Quebec
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Saint-Lambert, Quebec
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Sarnia, Ontario
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Saskatoon, Saskatchewan
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Scarborough Village, Ontario
Research Site
St. John's, Newfoundland and Labrador
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Surrey, British Columbia
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Terrebonne, Quebec
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Thetford-Mines, Quebec
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Thunder Bay, Ontario
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Toronto, Ontario
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Val-d'Or, Quebec
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Vancouver, British Columbia
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Victoria, British Columbia
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Windsor, Ontario

Other trials in Canada

Netherlands36 sites

Research Site
Almere Stad
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Amersfoort
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Amsterdam
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Arnhem
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Beverwijk
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Breda
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Delft
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Den Helder
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Deventer
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Drachten
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Ede
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Eindhoven
Research Site
Goes
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Groningen
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Hardenberg
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Heerenveen
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Heerlen
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Helmond
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Hilversum
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Hoofddorp
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Hoogeveen
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Leiderdorp
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Maastricht
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Nieuwegein
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Nijmegen
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Oss
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Roosendaal
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Rotterdam
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Schiedam
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Shertogenbosch
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Sittardgeleen
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Sneek
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The Hague
Research Site
Tiel
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Tilburg
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Veldhoven

Other trials in Netherlands

Poland30 sites

Research Site
Bialystok
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Bielsko-Biala
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Bydgoszcz
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Chorzów
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Gdansk
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Gdynia
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Giżycko
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Krakow
Research Site
Łańcut
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Łęczna
Research Site
Legnica
Research Site
Lodz
Research Site
Lubin
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Nowa Sól
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Oława
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Olsztyn
Research Site
Opole
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Ostrów Mazowiecka
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Piotrków
Research Site
Płock
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Poznan
Research Site
Skierniewice
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Sobótka
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Sokółka
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Szczecin
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Tarnów
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Torun
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Warsaw
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Włocławek
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Wroclaw

Other trials in Poland

Australia28 sites

Research Site
Adelaide
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Ashford
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Auchenflower
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Ballarat
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Bruce
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Chermside
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Clayton
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Concord
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East Saint Kilda
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Elizabeth Vale
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Epping
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Fremantle
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Geelong
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Gosford
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Greenslopes
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Herston
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Joondalup
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Kingswood
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Kogorah
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Launceston
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Melbourne
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Nedlands
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New Lambton Heights
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Richmond
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St Leonards
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Wollongong
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Woodville
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Woolloongabba

Other trials in Australia

Italy28 sites

Research Site
Albano Laziale
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Bari
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Benevento
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Brescia
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Carpi
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Catania
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Genova
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Legnano
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Lucca
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Massa
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Milan
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Naples
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Osio Sotto Frazione Di Zingoni
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Parma
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Pavia
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Perugia
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Pescara
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Pisa
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Reggio Emilia
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Roma
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Rozzano
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S Maria Capua Vetere
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Sanremo
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Sassari
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Sessa Aurunca
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Siena
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Sorrento NA
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Vimercate

Other trials in Italy

Belgium26 sites

Research Site
Aalst
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Antwerp
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Bonheiden
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Bouge
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Brasschaat
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Brussels
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Brussels (Anderlecht)
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Brussels (Jette)
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Brussels (Woluwé-St-Lambert)
Research Site
Charleroi
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Edegem
Research Site
Genk
Research Site
Ghent
Research Site
Hasselt
Research Site
Huy
Research Site
La Louvière
Research Site
Leuven
Research Site
Liège
Research Site
Mechelen
Research Site
Mol
Research Site
Ottignies
Research Site
Roeselare
Research Site
Tienen
Research Site
Turnhout
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Yvoir
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Zottegem

Other trials in Belgium

Germany25 sites

Research Site
Bad Krozingen
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Bad Mergentheim
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Bad Nauheim
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Berlin
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Bielefeld
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Coburg
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Deggingen
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Dortmund
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Dresden
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Essen
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Esslingen am Neckar
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Frankfurt
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Hamburg
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Heidelberg
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Kassel
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Kiel
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Leipzig
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Limburg
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Lübeck
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Ludwigshafen
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Mainz
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Mönchengladbach
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Ulm
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Warendorf
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Witten

Other trials in Germany

France23 sites

Research Site
Abbeville
Research Site
Albi
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Angers
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Avignon
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Bayonne
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Cannes
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Créteil
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Dijon
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Jossigny
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La Rochelle
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Le Chesnay
Research Site
Le Coudray
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Limoges
Research Site
Marseille
Research Site
Metz
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Nice
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Nîmes
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Orléans
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Paris
Research Site
Pessac
Research Site
Poitiers
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Toulouse
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Tourcoing

Other trials in France

United Kingdom23 sites

Research Site
Airdrie
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Antrim
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Belfast
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Blackpool
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Bournemouth
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Brighton
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Bristol
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Coventry
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Dundee
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East Kilbride
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Ely
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Hastings
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London
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Manchester
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Middlesbrough
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Northampton
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Nottingham
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Peterborough
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Rotherham
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Sheffield
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Swansea
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Torquay
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York

Other trials in United Kingdom

Czechia21 sites

Research Site
Brno
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Čáslav
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Česká Lípa
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Český Krumlov
Research Site
Chomutov
Research Site
Havířov
Research Site
Kroměříž
Research Site
Kyjov
Research Site
Liberec
Research Site
Mariánské Lázně
Research Site
Ostrava
Research Site
Ostrava-Poruba
Research Site
Pelhřimov
Research Site
Prague
Research Site
Příbram
Research Site
Slaný
Research Site
Teplice
Research Site
Ústí nad Labem
Research Site
Ústí nad Orlicí
Research Site
Zábřeh nad Odrou
Research Site
Znojmo

Other trials in Czechia

Argentina20 sites

Research Site
Bahía Blanca
Research Site
Buenos Aires
Research Site
Ciudad Autonoma de BA
Research Site
Ciudad de Buenos Aires
Research Site
Ciudadela
Research Site
Córdoba
Research Site
Coronel Suárez
Research Site
Corrientes
Research Site
Haedo
Research Site
La Plata
Research Site
Mar del Plata
Research Site
Ramos Mejía
Research Site
Rosario
Research Site
Rosario Santa Fe
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San Luis
Research Site
San Miguel de Tucumán
Research Site
San Nicolás
Research Site
San Salvador de Jujuy
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Santa Fe
Research Site
Zárate

Other trials in Argentina

Brazil20 sites

Research Site
Aracaju
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Belo Horizonte
Research Site
Blumenau
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Brasília
Research Site
Campina Grande do Sul
Research Site
Campinas
Research Site
Campo Grande
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Curitiba
Research Site
Goiânia
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Maceió
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Marília
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Porto Alegre
Research Site
Ribeirão Preto
Research Site
Rio de Janeiro
Research Site
S.J.Rio Preto
Research Site
Salvador
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São José do Rio Preto
Research Site
São Paulo
Research Site
Uberlândia
Research Site
Votuporanga

Other trials in Brazil

Hungary18 sites

Research Site
Ballasagyarmat
Research Site
Békéscsaba
Research Site
Budapest
Research Site
Cegléd
Research Site
Debrecen
Research Site
Eger
Research Site
Gyula
Research Site
Kalocsa
Research Site
Kecskemét
Research Site
Mosonmagyaróvár
Research Site
Nyíregyháza
Research Site
Pécs
Research Site
Sopron
Research Site
Szeged
Research Site
Székesfehérvár
Research Site
Szekszárd
Research Site
Szolnok
Research Site
Zalaegerszeg

Other trials in Hungary

Slovakia16 sites

Research Site
Banská Bystrica
Research Site
Bardejov
Research Site
Bratislava
Research Site
Komárno
Research Site
Košice
Research Site
Liptovský Hrádok
Research Site
Liptovský Mikuláš
Research Site
Martin
Research Site
Nitra
Research Site
Partizánske
Research Site
Piešťany
Research Site
Považská Bystrica
Research Site
Prešov
Research Site
Ružomberok
Research Site
Trnava
Research Site
Žilina

Other trials in Slovakia

Spain16 sites

Research Site
Almería
Research Site
Avilés
Research Site
Barcelona
Research Site
Bilbao
Research Site
Don Benito (Badajoz)
Research Site
Hospitalet de Llobregat(Barcel
Research Site
Madrid
Research Site
Majadahonda
Research Site
Málaga
Research Site
Oviedo
Research Site
Palma de Mallorca
Research Site
Sabadell
Research Site
San Sebastián de los Reyes
Research Site
Santiago(A Coruña)
Research Site
Seville
Research Site
Valencia

Other trials in Spain

Romania15 sites

Research Site
Bacau
Research Site
Brăila
Research Site
Brasov
Research Site
Bucharest
Research Site
Buzău
Research Site
Cluj-Napoca
Research Site
Craiova
Research Site
Deva
Research Site
Focşani
Research Site
Iași
Research Site
Piteşti
Research Site
Sibiu
Research Site
Suceava
Research Site
Tg. Mures
Research Site
Timișoara

Other trials in Romania

South Africa15 sites

Research Site
Alberton
Research Site
Bloemfontein
Research Site
Cape Town
Research Site
Centurion
Research Site
Durban
Research Site
Gatesville
Research Site
George
Research Site
Johannesburg
Research Site
Kempron Park
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About this study

Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction

Conditions: Myocardial Infarction, Cardiovascular Death, Atherothrombosis, Stroke
Being tested: Ticagrelor 90 mg, Ticagrelor 60 mg, Ticagrelor Placebo
Keywords: Heart attack, Heart Disease, Acute coronary syndrome, ACS, Cardiovascular Disease
Medical subject headings: Myocardial Infarction, Thrombosis, Stroke, Heart Diseases, Acute Coronary Syndrome, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ticagrelor 90 mgDrug
Oral dose twice a day
Ticagrelor 60 mgDrug
Oral dose twice a day
Ticagrelor PlaceboDrug
Oral dose twice a day

Study groups in NCT01225562
Study group	Role	What they receive
1	Experimental	Oral Treatment Receives: Drug: Ticagrelor 90 mg
2	Experimental	Oral Treatment Receives: Drug: Ticagrelor 60 mg
3	Placebo comparator	Oral Treatment Receives: Drug: Ticagrelor Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization
Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
Measured: Randomization up to 47 months
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients
A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug
Measured: First dosing up to 48 months

Secondary outcomes (2)

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization
Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization
Measured: Randomization up to 47 months
Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization
Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization
Measured: Randomization up to 47 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Dec 2014

First posted21 Oct 2010 (estimated)
Study startOct 2010
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21,379 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01225562
Sponsor's protocol ID: D5132C00001
Other IDs: 2009-017242-30, 2009
Acronym: PEGASUS
Status last verified: Dec 2015
First submitted: 9 Jul 2010
Last updated: 25 Jan 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.
PubMed 25773268
Bonaca MP, Im K, Magnani G, Bansilal S, Dellborg M, Storey RF, Bhatt DL, Steg PG, Cohen M, Johanson P, Braunwald E, Sabatine MS. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54. Eur Heart J. 2022 Dec 21;43(48):5037-5044. doi: 10.1093/eurheartj/ehac402.
PubMed 36367709
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730
Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Spinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.
PubMed 34423649
Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, Lopez-Sendon J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.
PubMed 33559485
Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.
PubMed 32410485
Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.
PubMed 32366163
Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.
PubMed 31811715
Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.
PubMed 31218354
Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Diaz R, Van de Werf F, Corbalan R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.
PubMed 30571502
Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.
PubMed 29406853
Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.
PubMed 29084737
Bonaca MP, Storey RF, Theroux P, Steg PG, Bhatt DL, Cohen MC, Im K, Murphy SA, Magnani G, Ophuis TO, Rudah M, Parkhomenko A, Isaza D, Kamensky G, Goudev A, Montalescot G, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017 Sep 12;70(11):1368-1375. doi: 10.1016/j.jacc.2017.07.768.
PubMed 28882235
Magnuson EA, Li H, Wang K, Vilain K, Shafiq A, Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Braunwald E, Sabatine MS, Cohen DJ; PEGASUS-TIMI 54 Trial Investigators. Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction: Results From the PEGASUS-TIMI 54 Trial. J Am Coll Cardiol. 2017 Aug 1;70(5):527-538. doi: 10.1016/j.jacc.2017.05.063.
PubMed 28750695
Thomas MR, Angiolillo DJ, Bonaca MP, Ajjan RA, Judge HM, Rollini F, Franchi F, Ahsan AJ, Bhatt DL, Kuder JF, Steg PG, Cohen M, Muthusamy R, Sabatine MS, Storey RF. Consistent platelet inhibition with ticagrelor 60 mg twice-daily following myocardial infarction regardless of diabetes status. Thromb Haemost. 2017 May 3;117(5):940-947. doi: 10.1160/TH16-09-0703. Epub 2017 Mar 16.
PubMed 28300867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction
ClinicalTrials.gov ID: NCT01225562
Acronym / sponsor ID: PEGASUS / D5132C00001
Conditions: Myocardial Infarction, Cardiovascular Death, Atherothrombosis, Stroke
Keywords: Heart attack, Heart Disease, Acute coronary syndrome, ACS, Cardiovascular Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 21,379 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 21 Oct 2010 (estimated)
Results: Posted 9 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Ticagrelor 90 mgOral Treatment
2	Experimental	Drug: Ticagrelor 60 mgOral Treatment
3	Placebo comparator	Drug: Ticagrelor PlaceboOral Treatment

Who may qualify

Ages: 50 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
Females of child-bearing potential must have a negative pregnancy test at enrollment
Persons who are currently taking aspirin between 75 and 150 mg once daily

Key exclusion criteria (11 listed)

Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
Persons with known bleeding disorders
Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
Persons with a history of ischemic stroke

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ticagrelor 90 mgOral dose twice a day	Drug	1
Ticagrelor 60 mgOral dose twice a day	Drug	2
Ticagrelor PlaceboOral dose twice a day	Drug	3

Primary outcome

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization
Time frame: Randomization up to 47 months
Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients
Time frame: First dosing up to 48 months
A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug

2 secondary outcomes

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization
Time frame: Randomization up to 47 months
Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization
Time frame: Randomization up to 47 months

Results and safety

Results posted to the registry on 9 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ticagrelor 90 mg	7,050	6,995
Ticagrelor 60 mg	7,045	6,989
Placebo	7,067	7,014

Primary outcome: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization

Time frame: Randomization up to 47 months. Number. Unit: Percentage of Patients

Measure	Ticagrelor 90 mg n = 7050	Ticagrelor 60 mg n = 7045	Placebo n = 7067
Value	7.8	7.8	9.0

Ticagrelor 90 mg vs Placebo: Hazard Ratio (HR): 0.85 (95% CI 0.75 to 0.96), p = 0.0080, Regression, Cox
Ticagrelor 60 mg vs Placebo: Hazard Ratio (HR): 0.84 (95% CI 0.74 to 0.95), p = 0.0043, Regression, Cox

Population analysed: Intention to treat (ITT) population defined as all participants who were randomized to study treatment

Primary outcome: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients

Time frame: First dosing up to 48 months. Number. Unit: Percentage of Patients

Measure	Ticagrelor 90 mg n = 6988	Ticagrelor 60 mg n = 6958	Placebo n = 6996
Value	2.6	2.3	1.1

Ticagrelor 90 mg vs Placebo: Hazard Ratio (HR): 2.69 (95% CI 1.96 to 3.70), p <0.0001, Regression, Cox
Ticagrelor 60 mg vs Placebo: Hazard Ratio (HR): 2.32 (95% CI 1.68 to 3.21), p <0.0001, Regression, Cox

Population analysed: The safety analysis set defined as all patients who took at least one dose of study drug

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1,757 of 6,996 (25.1%)	945 of 6,996 (13.5%)	Not reported
Ticagrelor 60mg bd	1,853 of 6,958 (26.6%)	1,992 of 6,958 (28.6%)	Not reported
Ticagrelor 90mg bd	1,918 of 6,988 (27.4%)	2,245 of 6,988 (32.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25773268Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.
Derived from this study: PubMed 36367709Bonaca MP, Im K, Magnani G, Bansilal S, Dellborg M, Storey RF, Bhatt DL, Steg PG, Cohen M, Johanson P, Braunwald E, Sabatine MS. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54. Eur Heart J. 2022 Dec 21;43(48):5037-5044. doi: 10.1093/eurheartj/ehac402.
Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Derived from this study: PubMed 34423649Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Spinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.
Derived from this study: PubMed 33559485Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, Lopez-Sendon J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.
Derived from this study: PubMed 32410485Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.
Derived from this study: PubMed 32366163Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.
Derived from this study: PubMed 31811715Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.
Derived from this study: PubMed 31218354Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.
Derived from this study: PubMed 30571502Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Diaz R, Van de Werf F, Corbalan R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.
Derived from this study: PubMed 29406853Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.
Derived from this study: PubMed 29084737Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.
D5132C00001\_ProtocolLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugene Braunwald, MD study chair

The TIMI Study Group

Marc Sabatine, MD, MPh principal investigator

The TIMI Study Group

826 sites in 31 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor 90 mg and Ticagrelor 60 mg in people with Myocardial Infarction and Cardiovascular Death, run by AstraZeneca at 826 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 826 sites in United States, Japan, Canada, Netherlands, Poland and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization (time frame: Randomization up to 47 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01225562, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.