Cardiovascular DiseasesPhase 3ACCELERATENCT01687998

A Study of Evacetrapib in High-Risk Vascular Disease

A Phase 3 study testing Evacetrapib in people with Cardiovascular Diseases, run by Eli Lilly and Company at 444 sites in 37 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiovascular Diseases
What is being tested?: Evacetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12,092 participants
Where: 444 sitesin 37 countries
Study dates: Oct 2012to Jul 2016
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of: 1)History of acute coronary syndrome (ACS) (that is, ≥30 days through 365 days after discharge for ACS) 2)cerebrovascular atherosclerotic disease 3)peripheral arterial disease 4)diabetes mellitus with documented coronary artery disease and are clinically stable (as judged by the responsible physician).
Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin must have documented statin intolerance, or contraindication to statin
Have a screening high-density lipoprotein cholesterol (HDL-C) ≤80 milligram per deciliter (mg/dL) (≤2.1 millimole per liter [mmol/L])
Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)
Meet 1 of the following criteria:
screening low-density lipoprotein cholesterol (LDL-C) no more than 10 mg/dL (0.3 mmol/L) above the target chosen by the investigator (either LDL-C <100 mg/dL [<2.6 mmol/L] or LDL-C <70 mg/dL [<1.8 mmol/L]), OR
if LDL-C is greater than target, the participant must be on maximum tolerated statin dose (for at least 30 days), have documented statin intolerance, or contraindication to statin

Who cannot join

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
Female participants who are known to be pregnant or breastfeeding
Women of child-bearing potential only, who test positive for pregnancy between screening and randomization, or who do not agree to use a reliable method of birth control during the study
History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30 days
Any reading of systolic blood pressure ≥180 millimeter of mercury (mm Hg) or diastolic blood pressure ≥110 mm Hg at screening or randomization

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History of hemorrhagic stroke or intracranial hemorrhage
New York Heart Association class III or IV congestive heart failure
Serum creatinine >2.2 mg/dL (>194.5 micromole per liter [μmol/L]) at screening
Clinically active liver disease. Participants are not excluded due to Gilbert's Syndrome or a history of cholelithiasis/cholecystectomy
History of malignancy within the preceding 3 years prior to screening
Known malabsorption syndrome with the exception of lactose intolerance
Participants with a known history of primary or secondary hyperaldosteronism
Participants with a history of intolerance/hypersensitivity to cholesterol ester transfer protein (CETP) inhibitors
Any clinically significant medical condition that according to the investigator could interfere with participation in the study
Participants whose life expectancy is anticipated to be less than 4 years
Unable or unwilling to comply with study requirements, or deemed by the investigator to be unfit for the study
Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator
Concurrent or anticipated need for treatment with niacin >250 mg/day or for chronic administration of drugs on the exclusion list
Previous exposure to the CETP inhibitors dalcetrapib or evacetrapib within the last 3 months or anacetrapib within the last 12 months
Any planned coronary angiography or coronary revascularization procedure. If angiography or revascularization is planned, participants may be screened and enrolled after all such planned procedures are completed.

Trial locations and contacts

444 sites in 37 countries.

Country

City, postcode or hospital

444 sites in 37 countries

United States176 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albany, New York, 12211
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Anderson, Indiana, 46011
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Arlington Heights, Illinois, 60005
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Asheville, North Carolina, 28803
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Auburn, Maine, 04210
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Aurora, Illinois, 60504
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Aventura, Florida, 33180
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Baltimore, Maryland, 21237
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Bangor, Maine, 04401
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Bannockburn, Illinois, 60015
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Baton Rouge, Louisiana, 70808
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Beachwood, Ohio, 44122
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Beaver, Pennsylvania, 15009
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Bellevue, Washington, 98004
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Bethlehem, Pennsylvania, 18018
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Birmingham, Alabama, 35233
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Bountiful, Utah, 84010
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Boynton Beach, Florida, 33472
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Brandon, Florida, 33511
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Bridgeport, Connecticut, 06606
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Bridgewater, New Jersey, 08807
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Brownsburg, Indiana, 46112
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Cadillac, Michigan, 49601
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Camp Hill, Pennsylvania, 17011
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Canton, Ohio, 44708
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Cary, North Carolina, 27518
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Chapel Hill, North Carolina, 27599
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Charlottesville, Virginia, 22908
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Cincinnati, Ohio, 45220
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44195
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Colorado Springs, Colorado, 80909
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Columbia, Maryland, 21044
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Columbia, Missouri, 65201
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Columbia, South Carolina, 29204
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Corpus Christi, Texas, 78404
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Cottonwood, Arizona, 86326
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Covington, Georgia, 30014
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Covington, Louisiana, 70433
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Cumberland, Rhode Island, 02864
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Cumming, Georgia, 30041
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Dallas, Texas, 75390
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Danville, Pennsylvania, 17822
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Danville, Virginia, 24541
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Elizabeth, New Jersey, 07202
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Elizabeth City, North Carolina, 27909
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Elkhart, Indiana, 46514
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Elmer, New Jersey, 08318
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Escondido, California, 92029
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Falls Church, Virginia, 22042
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Fleming Island, Florida, 32003
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Fort Smith, Arkansas, 72901
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Fort Wayne, Indiana, 46845
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Fresno, California, 93710
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Gainesville, Florida, 32605
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Glendale, Arizona, 85306
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Golden, Colorado, 80401
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Great Falls, Montana, 59405
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Green Bay, Wisconsin, 54303
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Greeneville, Tennessee, 37745
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Greensboro, North Carolina, 27408
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Greenville, South Carolina, 29607
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Greer, South Carolina, 29650
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Haddon Heights, New Jersey, 08035
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Hammond, Indiana, 46320
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Harrisonburg, Virginia, 22801
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Haverhill, Massachusetts, 01830
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Hershey, Pennsylvania, 17033
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Hickory, North Carolina, 28602
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Houston, Texas, 77074
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Huntington, West Virginia, 25701
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Huntsville, Alabama, 35801
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Hutchinson, Kansas, 67502
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Hyannis, Massachusetts, 02601
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Indianapolis, Indiana, 46290
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Inverness, Florida, 34452
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Jacksonville, Florida, 32258
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Jacksonville Beach, Florida, FL
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Jerseyville, Illinois, 62052
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Jupiter, Florida, 33458
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Kerrville, Texas, 78028
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Kingston, New York, 12401
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Kingwood, Texas, 77339
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Knoxville, Tennessee, 37917
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Lake Charles, Louisiana, 70601
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Lakeland, Florida, 33805
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Lansing, Michigan, 48910
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Largo, Florida, 33777
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Lenoir, North Carolina, 28645
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Lexington, Kentucky, 40536
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Little Rock, Arkansas, 72205
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Lomita, California, 90717
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Long Beach, California, 90822
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Louisville, Kentucky, 40207
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Lutherville, Maryland, 21093
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Lynchburg, Virginia, 24501
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Madison, Wisconsin, 53792
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Mansfield, Ohio, 44906
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Margate, Florida, 33063
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Marquette, Michigan, 49855
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Melbourne, Florida, 32901
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Miami, Florida, 33135
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Miami Beach, Florida, 33140
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Midland, Michigan, 48670
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Milwaukee, Wisconsin, 53295
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Mine Hill, New Jersey, 07803
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Minneapolis, Minnesota, 55417
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Mission Viejo, California, 92691
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Mobile, Alabama, 36608
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Murray, Utah, 84123
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Naples, Florida, 34102
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Nashville, Tennessee, 37203
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Natick, Massachusetts, 01760
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New York, New York, 10032
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Novi, Michigan, 48374
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Ocala, Florida, 34471
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Oklahoma City, Oklahoma, 73135
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Omaha, Nebraska, 68114
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Oregon, Wisconsin, 53575
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Orlando, Florida, 32803
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Overland Park, Kansas, 66209
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Panama City, Florida, 32401
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Pembroke Pines, Florida, 33026
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Pensacola, Florida, 32501
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Petoskey, Michigan, 49770
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Philadelphia, Pennsylvania, 19152
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Ponte Vedra, Florida, 32081
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Pontiac, Michigan, 48341
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Port Charlotte, Florida, 33952
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Port Matilda, Pennsylvania, 16870
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Portland, Oregon, 97225
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Pottstown, Pennsylvania, 19464
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Poughkeepsie, New York, 12601
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Rapid City, South Dakota, 57701
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Red Lion, Pennsylvania, 17356
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Ridgewood, New Jersey, 07450
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Roanoke, Virginia, 24014
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Rock Island, Illinois, 61201
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Safety Harbor, Florida, 34695
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Saginaw, Michigan, 48601
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Saint Cloud, Minnesota, 56303
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Saint Paul, Minnesota, 55101 2595
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Salisbury, Maryland, 21804
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Salt Lake City, Utah, 84124
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San Antonio, Texas, 78217
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Sandusky, Ohio, 44870
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Santa Rosa, California, 95405
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Saratoga Springs, New York, 12866
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Sewell, New Jersey, 08080
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Somerset, New Jersey, 08873
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Southampton, New York, 11968
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Springfield, Massachusetts, 01199
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Springfield, Missouri, 65804
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St Louis, Missouri, 63128
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Stockton, California, 95204
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Tacoma, Washington, 98405
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Tallahassee, Florida, 32308
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Teaneck, New Jersey, 07666
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Thousand Oaks, California, 91360
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Toledo, Ohio, 43606
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Tomball, Texas, 77375
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Toms River, New Jersey, 08755
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Torrance, California, 90509
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Troy, New York, 12180
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Tucker, Georgia, 30084
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Tucson, Arizona, 85724
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Tullahoma, Tennessee, 37388
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Tulsa, Oklahoma, 74136
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Waterbury, Connecticut, 06708
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Waterloo, Iowa, 50702
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Wellington, Florida, 33449
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Westfield, New York, 14787
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Wilkes-Barre, Pennsylvania, 18711
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Williamsville, New York, 14221
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Wilmington, North Carolina, 28401
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Zanesville, Ohio, 43701

Other trials in United States

Canada21 sites

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Brossard, Quebec, J4X 1S4
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Cambridge, Ontario, N1R 6V6
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Chicoutimi, Quebec, G7H 5H6
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Gatineau, Quebec, J8Y6S9
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Greater Sudbury, Ontario, P3E 2N8
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Greenfield Park, Quebec, J4V 2G8
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Hamilton, Ontario, L8L 2X2
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Joilette, Quebec, J6E 6J2
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Kelowna, British Columbia, V1Y 1V6
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Longueuil, Quebec, J4M 2X1
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Mississauga, Ontario, L5B 2P7
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Montreal, Quebec, H1T 1C8
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Mount Pearl, Newfoundland and Labrador, A1N 2C3
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Oshawa, Ontario, L1J 2J9
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Saint-Georges, Quebec, G5Y 4T8
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Saint-Jérôme, Quebec, J7Z 5T3
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Saint-Lambert, Quebec, J4P 2H4
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Sainte-Foy, Quebec, G1V 4G5
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Sarnia, Ontario, N7T 6K9
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Thunder Bay, Ontario, P7B 7C7
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Toronto, Ontario, M5C 2T2

Other trials in Canada

Japan18 sites

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Aichi, 470-1192
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Chiba, 270-2251
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Ehime, 798-8510
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Fukuoka, 830-8543
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Gunma, 377-0061
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Hyōgo, 665-0022
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Ibaraki, 311-3193
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Ishikawa, 920-8641
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Kanagawa, 232-0024
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Kumamoto, 860-8556
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Kyoto, 661-0042
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Okinawa, 901-0493
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Osaka, 581-0011
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Saitama, 351-0102
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Shizuoka, 411-8611
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Tokushima, 770-8539
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Tokyo, 152-8902
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Yamaguchi, 740-8510

Other trials in Japan

Netherlands18 sites

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's-Hertogenbosch, 5223 GV
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Amersfoort, 3818 ES
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Amsterdam, 1105 AZ
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Beverwijk, 1942 LE
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Delft, 2625 AD
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Den Helder, 1782 GZ
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Deventer, 7416 SE
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Drachten, 9202 NN
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Heerlen, 6401CX
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Hilversum, 1213 XZ
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Hoogeveen, 7909AA
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Hoorn, 1625 HV
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Leiden, 2333
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Tilburg, 5042 AD
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Venlo, 5912 BL
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Waalwijk, 5141 BM
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Zaandam, 1502 DV
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Zwijndrecht, 3331 LZ

Other trials in Netherlands

Germany15 sites

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Altenburg, 04600
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Bad Krozingen, 79189
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Berlin, 13347
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Bielefeld, 33604
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Dortmund, 44137
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Dresden, 01067
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Frankfurt, 65929
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Heidelberg, 69120
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Kassel, 34121
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Mainz, 55131
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Mönchengladbach, 41063
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Stuttgart, 70376
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Tübingen, D-72076
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Warendorf, 48231
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Wiesbaden, 65199

Other trials in Germany

Australia12 sites

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Box Hill, Victoria, 3128
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Camperdown, New South Wales, 2050
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Geelong, Victoria, 3220
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Heidelberg, Victoria, 3084
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Herston, Queensland, 4029
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Launceston, Tasmania, 7250
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Melbourne, Victoria, 3162
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Milton, Queensland, 4064
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Southport, Queensland, 4215
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Windsor, Victoria, 3183
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Wollongong, New South Wales, 2522
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Woodville, South Australia, 5011

Other trials in Australia

Poland12 sites

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Bydgoszcz, 85-863
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Gdansk, 80-126
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Katowice, 40-752
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Krakow, 30-510
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Kutno, 99-300
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Lodz, 94-255
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Oława, 55-200
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Puławy, 24-100
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Skierniewice, 96-100
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Sobótka, 55050
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Warsaw, 04-730
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Wroclaw, 51-112

Other trials in Poland

Hungary10 sites

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Békéscsaba, 5600
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Budapest, 1096
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Debrecen, 4025
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Esztergom, 2500
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Hódmezővásárhely, 6800
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Kalocsa, H-6300
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Komárom, 2921
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Orosháza, 5901
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Szekszárd, 7100
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Zalaegerszeg, 8900

Other trials in Hungary

Italy10 sites

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Bologna, 40138
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Castelfranco Veneto, 31033
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Chieti Scalo, 66013
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Milan, 20138
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Naples, 80131
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Novara, 28100
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Parma, 43100
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Piacenza, 29100
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San Daniele del Friuli, 33038
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Sessa Aurunca, 81037

Other trials in Italy

Mexico10 sites

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Aguascalientes, 20230
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Chihuahua City, 31238
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Cul Sinaloa, 80020
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Guadalajara, 44130
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Huixquilucan, 52763
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Mexico City, 11850
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Querétaro, 76000
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San Luis Potosí City, 78216
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Tampico, 89000
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Tijuana, 22500

Other trials in Mexico

South Africa9 sites

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Alberton, 1449
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Bellville, 7530
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Bloemfontein, 9300
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Goodwood, 7460
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Johannesburg, 1460
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Kuilsriver, 7580
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Newlands West, 4035
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Parktown West, 2193
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Worcester, 6850

Other trials in South Africa

United Kingdom9 sites

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Barnet, Herts, EN5 3DJ
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Bath, BA2 4BY
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Dudley, West Midlands, DY1 2HQ
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Frome, BA11 1EZ
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Saint Stephen, Cornwall, PL26 7RL
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Stevenage, Herts, SG4 7NH
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Tooting, London, SW17 ORE
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Wellingborough, Northants, NN8 4RW
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Welwyn Garden City, Hertfordshire, AL7 4HQ

Other trials in United Kingdom

Czechia8 sites

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Český Krumlov, 381 01
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Hodonín, 69501
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Mariánské Lázně, 35301
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Pardubice, 53002
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Písek, 39701
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Prague, 13000
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Příbram, 26101
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Teplice, 41501

Other trials in Czechia

South Korea8 sites

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Anyang, 431-070
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Busan, 614-735
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Daejeon, 301-721
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Gangwon-Do, 200-722
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Goyang, 410-773
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Gwangju, 510-757
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Jungbuk, 361-711
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Seoul, 137-701

Other trials in South Korea

France7 sites

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Bordeaux, 33000
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Dijon, 21000
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Le Coudray, 28630
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Paris, 75651
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Pessac, 33600
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Strasbourg, 67091
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Toulouse, 31059

Other trials in France

Israel7 sites

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Haifa, 31096
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Jerusalem, 91004
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Nazareth, 16100
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Rehovot, 76100
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Safed, 13110
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Tel Aviv, 64239
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Tel HaShomer, 52621

Other trials in Israel

Russia7 sites

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Arkhangelsk, 163045
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Kemerovo, 650002
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Moscow, 111020
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Saint Petersburg, 196105
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Smolensk, 214019
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Tomsk, 196105
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Yaroslavl, 150002

Other trials in Russia

Spain7 sites

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Ciudad Real, 13005
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Córdoba, 14004
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L'Hospitalet de Llobregat, 08907
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Madrid, 28040
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Málaga, 29010
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Palma de Mallorca, 07198
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Pamplona, 31008

Other trials in Spain

Argentina6 sites

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Belgrano, C1428DCO
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Buenos Aires, CBA 1425
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Córdoba, 5006
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Coronel Suárez, B7540GHD
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San Luis, D5702JRS
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San Miguel de Tucumán, T4000NIL

Other trials in Argentina

Bulgaria6 sites

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Gabrovo, 5300
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Pazardzhik, 4400
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Pleven, 5800
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Plovdiv, 4000
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Smolyan, 4700
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Sofia, 1527

Other trials in Bulgaria

China6 sites

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Beijing, 100034
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Changsha, 410005
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Guangzhou, 510515
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Harbin, 150001
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Shanghai, 200032
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Shenyang, 110004

Other trials in China

New Zealand6 sites

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Addington, 8011
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Grafton, 1023
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Hamilton West, 3204
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Newtown, 6021
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Tauranga, 3140
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Westlake, 0620

Other trials in New Zealand

Slovakia6 sites

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Bardejov, 08501
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Bratislava, 85101
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Kráľovský Chlmec, 07701
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Nitra, 949 01
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Prešov, 080 01
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Žilina, 010 01

Other trials in Slovakia

Taiwan6 sites

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Kaohsiung City, 807
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Kaohsiung City, 83301
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Kuei Shan Hsiang, 33305
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Taichung, 40201
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Taichung, 40705
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Taipei, 111

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Belgium5 sites

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Antwerp, 2060
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Brussels, 01200
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Huy, 4500
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Merksem, 2170
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Tienen, 3300

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Denmark5 sites

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Aalborg, 9000
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Ballerup Municipality, 2750
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Copenhagen, 2300
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Copenhagen, 2400
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Vejle, 7100

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Romania5 sites

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Brăila, 810249
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Bucharest, 022328
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Buzău, 120203
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Focşani, 620034
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Oradea, 410169

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Austria4 sites

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Feldkirch, 6807
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Graz, 8036
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Innsbruck, 6020
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Vienna, 1140

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Sweden4 sites

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Lund, 22221
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Malmö, 20502
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Östersund, 83183
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Stockholm, 11157

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Brazil3 sites

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Fortaleza, 60430-370
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Rio de Janeiro, 22271-100
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São Paulo, 05403-000

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Hong Kong3 sites

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Central
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Hong Kong
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Shatin

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Lithuania3 sites

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Kaunas, LT-50009
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Klaipėda, LT-92288
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Vilnius, LT-10323

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Puerto Rico3 sites

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Ponce, 00717-1322
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San Juan, 00909
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Trujillo Alto, 00976

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Ukraine3 sites

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Kyiv, 2091
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Lutsk, 43024
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Poltava, 36038

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Estonia2 sites

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Tallinn, 10128
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Viljandi, 71024

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Switzerland2 sites

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Lugano, CH-6900
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Zurich, CH-8091

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Turkey (Türkiye)2 sites

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Ankara, 06520
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Konya, 42250

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About this study

Official title: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

Conditions: Cardiovascular Diseases
Being tested: Evacetrapib, Placebo
Medical subject headings: Cardiovascular Diseases

What participants receive

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

EvacetrapibDrug
Also called LY2484595
Administered Orally
PlaceboDrug
Administered Orally

Study groups in NCT01687998
Study group	Role	What they receive
Evacetrapib	Experimental	Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD). Receives: Drug: Evacetrapib
Placebo	Placebo comparator	Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD. Receives: Drug: Placebo

What is being measured

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

Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Measured: Baseline to Study Completion (Up to 4 years)

Secondary outcomes (5)

Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels
Measured: Baseline, 3 Months
Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Measured: Baseline through End of Study (Up to 4 years)
Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Measured: Baseline through End of Study (Up to 4 years)
Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Measured: Baseline through End of Study (Up to 4 years)
Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Measured: Baseline through End of Study (Up to 4 years)

Timeline

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

Oct 2012Jul 2016

First posted19 Sep 2012 (estimated)
Study startOct 2012
Primary completionMar 2016
Study completionJul 2016

Why it stopped: Study termination due to insufficient efficacy.

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 (4)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12,092 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01687998
Sponsor's protocol ID: 11949
Other IDs: I1V-MC-EIAN
Acronym: ACCELERATE
Status last verified: Sep 2019
First submitted: 12 Sep 2012
Last updated: 8 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Oct 1;5(10):1136-1143. doi: 10.1001/jamacardio.2020.2413.
PubMed 32639518
Menon V, Kumar A, Patel DR, John JS, Wolski KE, McErlean E, Riesmeyer JS, Weerakkody G, Ruotolo G, Cremer PC, Nicholls SJ, Lincoff AM, Nissen SE. Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy. J Am Heart Assoc. 2020 Jan 7;9(1):e014328. doi: 10.1161/JAHA.119.014328. Epub 2019 Dec 19.
PubMed 31852422
Kumar A, Patel DR, Brennan DM, Wolski KE, Lincoff AM, Ruotolo G, McErlean E, Weerakkody G, Riesmeyer JS, Nicholls SJ, Nissen SE, Menon V. Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e013790. doi: 10.1161/JAHA.119.013790. Epub 2019 Nov 22.
PubMed 31752637
Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE; ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.
PubMed 28514624

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 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes
ClinicalTrials.gov ID: NCT01687998
Acronym / sponsor ID: ACCELERATE / 11949
Conditions: Cardiovascular Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study termination due to insufficient efficacy.
Enrolment: 12,092 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: The Cleveland Clinic
Study start: Oct 2012
Primary completion: Mar 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 19 Sep 2012 (estimated)
Results: Posted 16 May 2018

Clinical summary

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

The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Evacetrapib	Experimental	Drug: EvacetrapibEvacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
Placebo	Placebo comparator	Drug: PlaceboPlacebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of: 1)History of acute coronary syndrome (ACS) (that is, ≥30 days through 365 days after discharge for ACS) 2)cerebrovascular atherosclerotic disease 3)peripheral arterial disease 4)diabetes mellitus with documented coronary artery disease and are clinically stable (as judged by the responsible physician).
Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin must have documented statin intolerance, or contraindication to statin
Have a screening high-density lipoprotein cholesterol (HDL-C) ≤80 milligram per deciliter (mg/dL) (≤2.1 millimole per liter [mmol/L])
Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)
Meet 1 of the following criteria:

Key exclusion criteria (21 listed)

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
Female participants who are known to be pregnant or breastfeeding
Women of child-bearing potential only, who test positive for pregnancy between screening and randomization, or who do not agree to use a reliable method of birth control during the study
History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30 days

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
EvacetrapibAlso: LY2484595Administered Orally	Drug	Evacetrapib
PlaceboAdministered Orally	Drug	Placebo

Primary outcome

Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)
Time frame: Baseline to Study Completion (Up to 4 years)
For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.

5 secondary outcomes

Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels
Time frame: Baseline, 3 Months
Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA
Time frame: Baseline through End of Study (Up to 4 years)
Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization
Time frame: Baseline through End of Study (Up to 4 years)
Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA
Time frame: Baseline through End of Study (Up to 4 years)
Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke
Time frame: Baseline through End of Study (Up to 4 years)

Results and safety

Results posted to the registry on 16 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evacetrapib	6,038	5,926
Placebo	6,054	5,934

Primary outcome: Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)

Time frame: Baseline to Study Completion (Up to 4 years). Count of participants. Unit: Participants

Measure	Evacetrapib n = 6038	Placebo n = 6054
Value	779	776

Evacetrapib vs Placebo: Hazard Ratio (HR): 1.006 (95% CI 0.911 to 1.111), p = 0.9054, Regression, Cox

Population analysed: All randomized participants.

5 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
Evacetrapib	2,306 of 6,036 (38.2%)	2,659 of 6,036 (44.1%)	Not reported
Placebo	2,341 of 6,052 (38.7%)	2,529 of 6,052 (41.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32639518Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Oct 1;5(10):1136-1143. doi: 10.1001/jamacardio.2020.2413.
Derived from this study: PubMed 31852422Menon V, Kumar A, Patel DR, John JS, Wolski KE, McErlean E, Riesmeyer JS, Weerakkody G, Ruotolo G, Cremer PC, Nicholls SJ, Lincoff AM, Nissen SE. Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy. J Am Heart Assoc. 2020 Jan 7;9(1):e014328. doi: 10.1161/JAHA.119.014328. Epub 2019 Dec 19.
Derived from this study: PubMed 31752637Kumar A, Patel DR, Brennan DM, Wolski KE, Lincoff AM, Ruotolo G, McErlean E, Weerakkody G, Riesmeyer JS, Nicholls SJ, Nissen SE, Menon V. Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e013790. doi: 10.1161/JAHA.119.013790. Epub 2019 Nov 22.
Derived from this study: PubMed 28514624Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE; ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

444 sites in 37 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evacetrapib in people with Cardiovascular Diseases, run by Eli Lilly and Company at 444 sites in 37 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 7 inclusion and 21 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: stopped early, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 444 sites in United States, Canada, Japan, Netherlands, Germany and 32 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 16 May 2018). 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?

Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) (time frame: Baseline to Study Completion (Up to 4 years)). 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 NCT01687998, which also lists 4 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 8 Oct 2019.