Peripheral Artery DiseasePhase 3EUCLIDNCT01732822
A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease
A Phase 3 study testing Ticagrelor and Clopidogrel in people with Peripheral Artery Disease, run by AstraZeneca at 776 sites in 28 countries.
Trial summary
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease. Read more about this study
- Who is it for?
- Ages 50 to 130 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Ticagrelor and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,885 participants
- Where
- 776 sitesin 28 countries
- Study dates
- 4 Dec 2012to 26 Sep 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 50 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female patients 50 years old or older Symptomatic peripheral artery disease
Who cannot join
- Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation
- Patients with known bleeding disorders
- Patients with a history of intracranial bleed
- Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
Trial locations and contacts
776 sites in 28 countries.
776 sites in 28 countries
United States290 sites
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Albany, New York, 12211
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Albuquerque, New Mexico, 87108
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Alexander City, Alabama, 35010
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Alexandria, Louisiana, 71301
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Amarillo, Texas, 79106
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Anaheim, California, 92801
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Arlington Heights, Illinois, 60005
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Atlanta, Georgia, 30310
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Atlanta, Georgia, 30342
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Atlantis, Florida, 33462
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Auburn, Alabama, 36830
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Auburn, Maine, 04210
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Augusta, Georgia, 30901
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Austin, Texas, 78705
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Baltimore, Maryland, 21201
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Baton Rouge, Louisiana, 70808
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Belleville, New Jersey, 07109
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Beltsville, Maryland, 20705
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Berkeley, California, 94705
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Beverly Hills, California, 90210
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Biloxi, Mississippi, 39532
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Birmingham, Alabama, 35235
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Birmingham, Alabama, 35294
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Bossier City, Louisiana, 71111
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Bradenton, Florida, 34201
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Brandon, Florida, 33511
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Bridgeport, Connecticut, 06610
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Bridgewater, New Jersey, 08807
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Bristol, Tennessee, 37620
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Brooklyn, New York, 11215
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Brooksville, Florida, 34601
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Camden, New Jersey, 08103
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Camp Hill, Pennsylvania, 17011
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Canton, Ohio, 44710
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Centerville, Ohio, 45459
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Chapel Hill, North Carolina, 27599-7081
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Charleston, South Carolina, 29425
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Charleston, West Virginia, 25304
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Charlotte, North Carolina, 28204
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Charlottesville, Virginia, 22908
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Chicago, Illinois, 60611
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Chicago, Illinois, 60616
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Chula Vista, California, 91911-1350
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Cincinnati, Ohio, 45267-0769
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44106
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Cleveland, Ohio, 44195
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Columbia, Maryland, 21044
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Columbia, South Carolina, 29204
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Concord, North Carolina, 28025
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Corpus Christi, Texas, 78404
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Cottonwood, Arizona, 86326
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Cumming, Georgia, 30041
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Dallas, Texas, 75216
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Dayton, Ohio, 45414
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Daytona Beach, Florida, 32114
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Daytona Beach, Florida, 32117
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Doylestown, Pennsylvania, 18901
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Duluth, Minnesota, 55805
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Dunmore, Pennsylvania, 18509
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Easley, South Carolina, 29640
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East Orange, New Jersey, 07018-1095
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Eatontown, New Jersey, 07724
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Edgewood, Kentucky, 41071-3441
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El Cajon, California, 92020
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Elkhart, Indiana, 46514
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Elmer, New Jersey, 08318
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Erie, Pennsylvania, 16502
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Erie, Pennsylvania, 16550
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Fall River, Massachusetts, 02720
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Falls Church, Virginia, 22042
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Fargo, North Dakota, 58103
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Fargo, North Dakota, 58122-0352
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Flemington, New Jersey, 08822
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Flint, Michigan, 48503
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Flint, Michigan, 48532
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Fort Myers, Florida, 33907
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Fort Smith, Arkansas, 72901
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Fort Wayne, Indiana, 46804
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Fort Wayne, Indiana, 46845
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Fort Worth, Texas, 76104
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Fort Worth, Texas, 76117
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Freehold, New Jersey, 07728
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Fresno, California, 93721
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Friendswood, Texas, 77546
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Gainesville, Florida, 32605
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Grand Rapids, Michigan, 49503
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Greenbelt, Maryland, 20770
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Greensboro, North Carolina, 27401
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Greenville, South Carolina, 29615
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Greenwood, South Carolina, 29646
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Guilford, Connecticut, 06437
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Hackensack, New Jersey, 07601
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Haddon Heights, New Jersey, 08035
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Haverhill, Massachusetts, 01830
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Hawthorne, New York, 10532
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Hershey, Pennsylvania, 17033
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High Point, North Carolina, 27262
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Hillsboro, Oregon, 97123-4117
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Hinsdale, Illinois, 60521
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Houston, Texas, 77030
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Houston, Texas, 77339
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Hudson, Florida, 34667
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Hurst, Texas, 76054
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Idaho Falls, Idaho, 83404
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Indianapolis, Indiana, 46237
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Indianapolis, Indiana, 46260
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Iowa City, Iowa, 52242
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Jackson, Mississippi, 39216
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Jackson, Tennessee, 38301
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Jacksonville, Florida, 32205
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Jacksonville, Florida, 32207
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Jacksonville, Florida, 32209
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Jacksonville, Florida, 32216
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Jacksonville, Florida, 32258
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Johnson City, New York, 13790
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Jonesboro, Arkansas, 72401
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Kalamazoo, Michigan, 49008
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Kalispell, Montana, 59901
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Kansas City, Missouri, 64111
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Kettering, Ohio, 45429
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Killeen, Texas, 76549
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Knoxville, Tennessee, 37934
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La Jolla, California, 92093
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La Mesa, California, 91942
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Laguna Hills, California, 92653
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Langhorne, Pennsylvania, 19047
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Lansing, Michigan, 48910
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Largo, Florida, 33777
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Las Vegas, Nevada, 89121
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Las Vegas, Nevada, 89146
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Leesburg, Virginia, 20176
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Lenoir, North Carolina, 28645
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Lincoln, Nebraska, 68506
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Lincoln, Nebraska, 68526
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Linden, New Jersey, 07036
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Lithonia, Georgia, 30058
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Little Rock, Arkansas, 72205
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Liverpool, New York, 13088
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Long Beach, California, 90822
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Louisville, Kentucky, 40205
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Loveland, Colorado, 80538
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Lubbock, Texas, 79410
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Lynchburg, Virginia, 24501
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Macon, Georgia, 31217
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Madison, Wisconsin, 52713
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Manassas, Virginia, 20109
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Manitowoc, Wisconsin, 54220
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Martinez, Georgia, 30907
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McAllen, Texas, 78501
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McAllen, Texas, 78503
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McKinney, Texas, 75069
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Memphis, Tennessee, 38104
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Merrillville, Indiana, 46410
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Mesa, Arizona, 85206
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Miami, Florida, 33173
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Miami, Florida, 33176
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Midlothian, Virginia, 23114
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Milwaukee, Wisconsin, 53215
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Minneapolis, Minnesota, 55407
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Minneapolis, Minnesota, 55454
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Minot, North Dakota, 58701
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Mission Viejo, California, 92691
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Mobile, Alabama, 36604
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Mobile, Alabama, 36608
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Mobile, Alabama, 36617
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Mooresville, North Carolina, 28117
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Moreno Valley, California, 92553
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Mount Clemens, Michigan, 48043
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Muncie, Indiana, 47303
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Munster, Indiana, 46321
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Muskegon, Michigan, 49444
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Nashville, Tennessee, 37203
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Nashville, Tennessee, 37232-0700
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New Brunswick, New Jersey, 08901
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New York, New York, 10001
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New York, New York, 10016
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New York, New York, 10029
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Newark, Delaware, 19713
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Newark, Delaware, 19718-0002
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Newark, New Jersey, 07102
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Newark, New Jersey, 07103
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Newport, Pennsylvania, 17074
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North Las Vegas, Nevada, 89086
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North Richland Hills, Texas, 76180
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Northridge, California, 91325-4139
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Norwalk, Connecticut, 06851
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Ocala, Florida, 34471
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Ocean City, New Jersey, 07712
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Oceanside, California, 92056
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Odessa, Texas, 79761
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Ogden, Utah, 84403
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Oklahoma City, Oklahoma, 73104
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Oklahoma City, Oklahoma, 73120
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Orange, California, 92868
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Orange Park, Florida, 32003
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Owensboro, Kentucky, 42303
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Palm Harbor, Florida, 34684
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Palo Alto, California, 94304-1290
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Pawtucket, Rhode Island, 02860
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Pensacola, Florida, 32501
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Philadelphia, Pennsylvania, 19102
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19106
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Philadelphia, Pennsylvania, 19115
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Philadelphia, Pennsylvania, 19140
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Philadelphia, Pennsylvania, 19153
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Phoenix, Arizona, 85006
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Phoenix, Arizona, 85012
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Plantation, Florida, 33324
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Poughkeepsie, New York, 12601
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Puyallup, Washington, 98372
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Raleigh, North Carolina, 27609
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Raleigh, North Carolina, 27610
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Rapid City, South Dakota, 57701
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Rock Island, Illinois, 61201
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Rockford, Illinois, 61108
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Rocky Mount, North Carolina, 27804
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Round Rock, Texas, 78681
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Sacramento, California, 95816
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Sacramento, California, 95817
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Safety Harbor, Florida, 34695
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Saint Cloud, Minnesota, 56303
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Salt Lake City, Utah, 84132
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San Diego, California, 92114
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San Diego, California, 92120
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San Francisco, California, 94143-0222
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Sarasota, Florida, 34239
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Saratoga Springs, New York, 12866
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Savannah, Georgia, 31404
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Sayre, Pennsylvania, 18840
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Scottsdale, Arizona, 85260
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Sellersville, Pennsylvania, 18960
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Sewell, New Jersey, 08080
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Shreveport, Louisiana, 71103
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Shreveport, Louisiana, 71105
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South Charleston, West Virginia, 25309
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Spokane, Washington, 99204
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Spokane, Washington, 99210
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Springfield, Ohio, 45504
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St Louis, Missouri, 63104
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St Louis, Missouri, 63128
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St Louis, Missouri, 63136
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St Louis, Missouri, 63141
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St. Petersburg, Florida, 33701
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St. Petersburg, Florida, 33709
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Stamford, Connecticut, 06905
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Statesville, North Carolina, 28625
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Stockton, California, 95210
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Stuart, Florida, 34996
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Summit, New Jersey, 07902
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Tacoma, Washington, 98405
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Tallahassee, Florida, 32308
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Tampa, Florida, 33606
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Tampa, Florida, 33613
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The Bronx, New York, 10461
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The Bronx, New York, 10469
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Toledo, Ohio, 43606
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Torrance, California, 90505-5073
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Torrance, California, 90509
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Trinity, Florida, 34655
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Troy, New York, 12180
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Trumbull, Connecticut, 06611
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Tucker, Georgia, 30084
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Tupelo, Mississippi, 38801
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Tyler, Texas, 75701
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Tyler, Texas, 75708
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Valparaiso, Indiana, 46383
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Vero Beach, Florida, 32960
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Victoria, Texas, 77901
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Voorhees Township, New Jersey, 08043
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Washington D.C., District of Columbia, 20422
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Wausau, Wisconsin, 54401
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Webster, Texas, 77598
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Wellington, Florida, 33449
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West Des Moines, Iowa, 50266
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West Orange, New Jersey, 07052
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West Palm Beach, Florida, 33401
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Williamsville, New York, 14221
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Wilmington, Delaware, 19803
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Wilmington, North Carolina, 28401
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Winchester, Virginia, 22601
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Winston-Salem, North Carolina, 27103
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Worcester, Massachusetts, 01655
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Wormleysburg, Pennsylvania, 17043
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Wyomissing, Pennsylvania, 19610
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Yonkers, New York, 10701
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York, Pennsylvania, 17403
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Youngstown, Ohio, 44501
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Zanesville, Ohio, 43701
Japan38 sites
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Asahi-shi, 289-2511
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Beppu-shi, 874-0011
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Fukuoka, 810-0001
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Hamada-shi, 697-8511
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Himeji-shi, 671-1227
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Imabari, 799-1592
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Kasuga-shi, 816-0864
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Kishiwada-shi, 596-8522
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Kobe, 651-0053
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Koriyama-shi, 963-8052
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Kyoto, 607-8062
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Matsubara-shi, 580-0032
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Matsuyama, 790-8524
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Matsuyama, 791-8026
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Meguro-ku, 152-8902
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Mito, 310-0011
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Miura-gun, 240-0116
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Ogori-shi, 838-0141
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Ōita, 870-0192
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Sakaide-shi, 762-0007
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Sapporo, 060-0031
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Sapporo, 060-0033
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Sapporo, 063-0005
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Sapporo, 065-0027
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Shinjuku-ku, 162-8655
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Shizuoka, 420-0853
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Suwa-shi, 392-8510
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tabashi City, 173-8610
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Toyonaka-shi, 560-8565
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Tsu, 514-8507
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Uji-shi, 611-0041
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Wakayama, 640-8158
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Yamagata, 990-8545
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Yatsushiro-shi, 866-8533
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Yokohama, 231-0023
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Yokohama, 234-8503
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Yokohama, 236-0004
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Yokosuka-shi, 238-8567
Russia31 sites
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Arkhangelsk, 163001
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Chelyabinsk, 454021
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Gatchina, 188300
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Kazan', 420043
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Kazan', 420101
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Moscow, 117292
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Moscow, 117630
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Moscow, 127018
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Moscow, 129090
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Nizhny Novgorod, 603018
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Novosibirsk, 630055
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Perm, 614000
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Perm, 614107
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Perm, 6144090
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Rostov-on-Don, 344022
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Saint Petersburg, 191015
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Saint Petersburg, 192242
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Saint Petersburg, 194354
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Saint Petersburg, 195271
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Saint Petersburg, 197022
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Saint Petersburg, 197374
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Saint Petersburg, 197706
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Saint Petersburg, 198260
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Saint Petersburg
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Saratov, 410028
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Tomsk, 234012
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Tomsk, 634012
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Tver', 170036
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Vladikavkaz, 362007
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Yekaterinburg, 620039
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Yekaterinburg, 620149
Spain27 sites
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A Coruña, 15006
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Albacete, 02006
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Alcorcón, 28922
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Alicante, 03010
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Badalona (Barcelona), 08916
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Badalona(Barcelona), 08916
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Barcelona, 08023
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Barcelona, 08025
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Boadilla del Monte, 28660
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Getafe, 29905
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Granada, 18012
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Hospitalet de Llobregat(Barcel, 08907
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Huelva, 21005
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Lleida, 25198
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Madrid, 28007
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Madrid, 28028
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Madrid, 28040
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Madrid, 28046
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Málaga, 29010
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Mallorca, 07120
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Manises, 46940
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Oviedo, 33006
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Sabadell, 08208
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Tarragona, 43005
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Toledo, 45004
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Valencia, 46014
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Valencia, 46026
Canada26 sites
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Brampton, Ontario, L6Z 4N5
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Bridgewater, Nova Scotia, B4V 3N2
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Brossard, Quebec, J4Z 2K9
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Chicoutimi, G7H 5H6
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Gatineau, Quebec, J8Y 6S8
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Greenfield Park, Quebec, J4V 2G8
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Guelph, Ontario, N1H 1B1
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London, Ontario, N6A 5W9
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Montreal, Quebec, H1M 1B1
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Montreal, Quebec, H1T 1C8
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Montreal, Quebec, H1T 3Y7
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North York, Ontario, M3M 3E5
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Ottawa, Ontario, K1K 4L2
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Ottawa, Ontario, K1Y 4E9
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1L 3L5
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Québec, Quebec, G1N 4V3
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Québec, Quebec, G3K 2P8
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Saint-Charles-Borromée, Quebec, J6E 6J2
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Smiths Falls, Ontario, K7A 4W8
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St. John's, Newfoundland and Labrador, A1A 3R5
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St. John's, Newfoundland and Labrador, A1C 5B8
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Toronto, Ontario, M5B 1W8
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Trois-Rivières, Quebec, G8Z 3R9
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Vancouver, British Columbia, V5Z 1M9
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Winnipeg, Manitoba, R2H 2A6
Brazil25 sites
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Belo Horizonte, 30110-100
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Belo Horizonte, 30110070
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Belo Horizonte, 30150-240
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Belo Horizonte, 30190-130
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Brasília, 70710-905
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Campinas, 13010-001
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Campinas, 13060 904
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Canoas, 92425-900
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Curitiba, 80010-030
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Curitiba, 80730-150
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Juiz de Fora, 36010 570
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Porto Alegre, 90035903
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Porto Alegre, 90610-000
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Porto Alegre, 90620-001
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Rio de Janeiro, 20551-030
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Salvador, 40140-110
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Salvador, 41810-010
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Santo André, 09060-650
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São Bernardo do Campo, 09715090
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São José do Rio Preto, 15015210
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São José do Rio Preto, 15090-000
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São Paulo, 04039-000
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São Paulo, 05017-00
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Tatuí, 18270-170
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Uberlândia, 38400-368
France25 sites
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Amiens, 80054
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Bayonne, 64100
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Bordeaux, 33075
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Brest, 29609
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Caen, F-14033
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Castelnau-le-Lez, F-34170
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Dijon, 21079
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La Tronche, 38700
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Le Chesnay, 78157
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Le Coudray, 28630
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Limoges, 87042
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Montpellier, 34295
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Nantes, 44277
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Paris, 75651
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Paris, 75674
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Paris, 75908
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Pessac, 33604
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Rambouillet, 78120
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Saint-Priest-en-Jarez, 42270
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Strasbourg, 67091
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Thionville, 57100
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Toulouse, 31059
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Toulouse, 31076
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Tours, 37044
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Vandœuvre-lès-Nancy, 54511
Germany25 sites
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Berlin, 10713
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Berlin, 10787
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Berlin, 12203
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Dresden, 01099
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Dresden, 01219
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Dresden, 01307
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Dresden, 1067
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Erlangen, 91054
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Ettlingen, 76275
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Frankfurt am Main, 60590
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Hamburg, 20099
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Hamburg, 20246
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Hamburg, 22041
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Hamburg, 22559
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Heidelberg, 69120
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Kaiserslautern, 67657
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Leipzig, 04103
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Mainz, 55131
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Merseburg, 06217
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München, 80331
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München, 80336
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München, 80638
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Riesa, 01587
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Tübingen, 72076
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Wesel, 46483
China24 sites
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Beijing, 100029
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Beijing, 100038
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Beijing, 100191
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Beijing, 100853
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Changsha, 410008
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Changsha, 410013
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Fuzhou, 350025
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Haerbin, 150001
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Hubei, 430022
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Nanjing, 2100008
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Nanjing, 210029
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Qingdao, 266003
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Shanghai, 200000
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Shanghai, 200001
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Shanghai, 200032
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Shanghai, 200080
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Shanghai, 200127
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Shanghai, CN-200092
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Taiyuan, 030001
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Tianjin, 300121
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Tianjin, CN-300052
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Wuhan, 430022
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Wuxi, 214023
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Xi'an, 710061
Poland24 sites
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Bialystok, 15-111
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Bydgoszcz, 85-094
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Bydgoszcz, 85-231
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Gdynia, 81-157
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Gdynia, 81-402
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Gdynia, 81-423
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Gdynia, 81-472
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Grodzisk Mazowiecki, 05-825
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Katowice, 40-954
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Krakow, 30-529
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Krakow, 31-202
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Łęczna, 21-010
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Lodz, 90-338
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Lodz, 94-238
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Lublin, 20-044
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Ostrów Mazowiecka, 07-300
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Tarnów, 33-100
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Torun, 87-100
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Warsaw, 00-899
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Warsaw, 01-211
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Warsaw, 01-868
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Warsaw, 04-628
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Wroclaw, 51-124
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Zamość, 22-400
Italy23 sites
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Ancona, 60122
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Avellino, 83100
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Castelfranco Veneto, 31033
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Catania, 95100
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Catania, 95124
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Chieti, 66013
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Genova, 16132
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Lecce, 7310
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Milan, 20138
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Milan, 20162
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Naples, 80100
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Naples, 80131
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Oristano, 09170
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About this study
Official title: A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
Read the detailed description
A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
- Conditions
- Peripheral Artery Disease
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- Peripheral artery disease Atherothrombotic events Atherosclerosis
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta/Brilique
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
ClopidogrelDrug
Also called Plavix
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets Receives: Drug: Ticagrelor |
| Clopidogrel | Active comparator | Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke
Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)
Measured: From randomization to PACD, an average of 2.5 years
Secondary outcomes (8)
Composite of CV Death, MI, Ischemic Stroke, and ALI
Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)
Measured: From randomization to PACD, an average of 2.5 years
CV Death
Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)
Measured: From randomization to PACD, an average of 2.5 years
MI
Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)
Measured: From randomization to PACD, an average of 2.5 years
All-cause Mortality
Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)
Measured: From randomization to PACD, an average of 2.5 years
Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)
Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)
Measured: From randomization to PACD, an average of 2.5 years
ALI
Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)
Measured: From randomization to PACD, an average of 2.5 years
Lower Extremity Revascularization
Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)
Measured: From randomization to PACD, an average of 2.5 years
Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])
Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)
Measured: From randomization to PACD, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study start4 Dec 2012
- Primary completion26 Sep 2016
- Study completion26 Sep 2016
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 (23)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies 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
- 13,885 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William R Hiatt, MD, Study chair, University of Colorado School of MedicinePeter Held, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732822
- Sponsor's protocol ID
- D5135C00001
- Other IDs
- 2011-004616-36
- Acronym
- EUCLID
- Status last verified
- Sep 2017
- First submitted
- 20 Nov 2012
- Last updated
- 30 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Szarek M, Hess C, Patel MR, Jones WS, Berger JS, Baumgartner I, Katona B, Mahaffey KW, Norgren L, Blomster J, Rockhold FW, Hsia J, Fowkes FGR, Bonaca MP. Total Cardiovascular and Limb Events and the Impact of Polyvascular Disease in Chronic Symptomatic Peripheral Artery Disease. J Am Heart Assoc. 2022 Jun 7;11(11):e025504. doi: 10.1161/JAHA.122.025504. Epub 2022 May 27.
PubMed 35621222Govsyeyev N, Nehler MR, Low Wang CC, Kavanagh S, Hiatt WR, Long C, Jones WS, Fowkes FGR, Berger JS, Baumgartner I, Patel MR, Goodney PP, Beckman JA, Katona BG, Mahaffey KW, Blomster J, Norgren L, Bonaca MP. Etiology and outcomes of amputation in patients with peripheral artery disease in the EUCLID trial. J Vasc Surg. 2022 Feb;75(2):660-670.e3. doi: 10.1016/j.jvs.2021.08.096. Epub 2021 Sep 28.
PubMed 34597783Norgren L, North R, Baumgartner I, Berger JS, Blomster JI, Hiatt WR, Jones WS, Katona BG, Mahaffey KW, Mulder H, Patel MR, Rockhold FW, Fowkes FGR. World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial. Vasc Med. 2022 Feb;27(1):21-29. doi: 10.1177/1358863X211038620. Epub 2021 Sep 13.
PubMed 34516308Hiatt WR, Hess CN, Bonaca MP, Kavanagh S, Patel MR, Baumgartner I, Berger JS, Blomster JI, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Fowkes FGR. Ankle-Brachial Index for Risk Stratification in Patients With Symptomatic Peripheral Artery Disease With and Without Prior Lower Extremity Revascularization: Observations From the EUCLID Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e009871. doi: 10.1161/CIRCINTERVENTIONS.120.009871. Epub 2021 Jul 13.
PubMed 34253048Hsia J, Kavanagh ST, Hopley CW, Baumgartner I, Berger JS, Fowkes GR, Jones WS, Mahaffey KW, Norgren L, Patel MR, Rockhold F, Blomster J, Katona BG, Hiatt WR, Bonaca MP. Impact of chronic kidney disease on hemoglobin among patients with peripheral artery disease treated with P2Y12 inhibitors: Insights from the EUCLID trial. Vasc Med. 2021 Dec;26(6):608-612. doi: 10.1177/1358863X211017641. Epub 2021 Jun 3.
PubMed 34082620Galani J, Mulder H, Rockhold FW, Weissler EH, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Hiatt WR, Katona BG, Norgren L, Mahaffey KW, Quint JK, Patel MR, Jones WS. Association of Chronic Obstructive Pulmonary Disease with Morbidity and Mortality in Patients with Peripheral Artery Disease: Insights from the EUCLID Trial. Int J Chron Obstruct Pulmon Dis. 2021 Mar 29;16:841-851. doi: 10.2147/COPD.S292978. eCollection 2021.
PubMed 33824584Kochar A, Mulder H, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Lopes RD, Al-Khalidi HR, Mahaffey KW, Norgren L, Hiatt WR, Patel MR, Jones WS. Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006550. doi: 10.1161/CIRCOUTCOMES.120.006550. Epub 2020 Nov 12.
PubMed 33176462Gutierrez JA, Heizer GM, Jones WS, Rockhold FW, Mahaffey KW, Fowkes FGR, Berger JS, Baumgartner I, Held P, Katona BG, Norgren L, Blomster JI, Hiatt WR, Patel MR. CYP2C19 status and risk of major adverse cardiovascular events in peripheral artery disease: Insights from the EUCLID Trial. Am Heart J. 2020 Nov;229:118-120. doi: 10.1016/j.ahj.2020.07.017. Epub 2020 Aug 16. No abstract available.
PubMed 32950849Fudim M, Hopley CW, Huang Z, Kavanagh S, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Ostrom C, Patel MR, Jones WS, Hiatt WR. Association of Hypertension and Arterial Blood Pressure on Limb and Cardiovascular Outcomes in Symptomatic Peripheral Artery Disease: The EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006512. doi: 10.1161/CIRCOUTCOMES.120.006512. Epub 2020 Aug 31.
PubMed 32862697Long CA, Mulder H, Fowkes FGR, Baumgartner I, Berger JS, Katona BG, Mahaffey KW, Norgren L, Blomster JI, Rockhold FW, Hiatt WR, Patel MR, Jones WS, Nehler MR. Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Jul;13(7):e006399. doi: 10.1161/CIRCOUTCOMES.119.006399. Epub 2020 Jul 3.
PubMed 32615798Haine A, Kavanagh S, Berger JS, Hess CN, Norgren L, Fowkes FGR, Katona BG, Mahaffey KW, Blomster JI, Patel MR, Jones WS, Rockhold FW, Hiatt WR, Baumgartner I; International Steering Committee and Investigators of the EUCLID Trial. Sex-Specific Risks of Major Cardiovascular and Limb Events in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2020 Feb 18;75(6):608-617. doi: 10.1016/j.jacc.2019.11.057.
PubMed 32057375Ward R, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Vemulapalli S, Povsic TJ, Mehta R, Hiatt WR, Patel MR, Jones WS. Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. Am Heart J. 2020 Feb;220:51-58. doi: 10.1016/j.ahj.2019.11.007. Epub 2019 Nov 18.
PubMed 31783279Hopley CW, Kavanagh S, Patel MR, Ostrom C, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial. Vasc Med. 2019 Oct;24(5):422-430. doi: 10.1177/1358863X19864172. Epub 2019 Jul 24.
PubMed 31339474Hess CN, Huang Z, Patel MR, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Held P, Jones WS, Katona B, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Acute Limb Ischemia in Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):556-565. doi: 10.1161/CIRCULATIONAHA.119.039773. Epub 2019 Jun 26.
PubMed 31238713Kolls BJ, Sapp S, Rockhold FW, Jordan JD, Dombrowski KE, Fowkes FGR, Mahaffey KW, Berger JS, Katona BG, Blomster JI, Norgren L, Abramson BL, Leiva-Pons JL, Prieto JC, Sokurenko G, Hiatt WR, Jones WS, Patel MR. Stroke in Patients With Peripheral Artery Disease. Stroke. 2019 Jun;50(6):1356-1363. doi: 10.1161/STROKEAHA.118.023534. Epub 2019 May 16.
PubMed 31092165
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
- ClinicalTrials.gov ID
- NCT01732822
- Acronym / sponsor ID
- EUCLID / D5135C00001
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral artery disease Atherothrombotic events Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,885 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Posted 30 Oct 2017
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 this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
Detailed description
A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets |
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets |
Who may qualify
- Ages
- 50 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and Female patients 50 years old or older Symptomatic peripheral artery disease
Key exclusion criteria (4 listed)
- Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation
- Patients with known bleeding disorders
- Patients with a history of intracranial bleed
- Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
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 |
|---|---|---|
| TicagrelorAlso: Brilinta/BriliqueTicagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets | Drug | Ticagrelor |
| ClopidogrelAlso: PlavixClopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets | Drug | Clopidogrel |
Primary outcome
Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke
Time frame: From randomization to PACD, an average of 2.5 years
Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)
8 secondary outcomes
Composite of CV Death, MI, Ischemic Stroke, and ALI
Time frame: From randomization to PACD, an average of 2.5 years
CV Death
Time frame: From randomization to PACD, an average of 2.5 years
MI
Time frame: From randomization to PACD, an average of 2.5 years
All-cause Mortality
Time frame: From randomization to PACD, an average of 2.5 years
Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)
Time frame: From randomization to PACD, an average of 2.5 years
ALI
Time frame: From randomization to PACD, an average of 2.5 years
Lower Extremity Revascularization
Time frame: From randomization to PACD, an average of 2.5 years
Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])
Time frame: From randomization to PACD, an average of 2.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35621222Szarek M, Hess C, Patel MR, Jones WS, Berger JS, Baumgartner I, Katona B, Mahaffey KW, Norgren L, Blomster J, Rockhold FW, Hsia J, Fowkes FGR, Bonaca MP. Total Cardiovascular and Limb Events and the Impact of Polyvascular Disease in Chronic Symptomatic Peripheral Artery Disease. J Am Heart Assoc. 2022 Jun 7;11(11):e025504. doi: 10.1161/JAHA.122.025504. Epub 2022 May 27.
- Derived from this study: PubMed 34597783Govsyeyev N, Nehler MR, Low Wang CC, Kavanagh S, Hiatt WR, Long C, Jones WS, Fowkes FGR, Berger JS, Baumgartner I, Patel MR, Goodney PP, Beckman JA, Katona BG, Mahaffey KW, Blomster J, Norgren L, Bonaca MP. Etiology and outcomes of amputation in patients with peripheral artery disease in the EUCLID trial. J Vasc Surg. 2022 Feb;75(2):660-670.e3. doi: 10.1016/j.jvs.2021.08.096. Epub 2021 Sep 28.
- Derived from this study: PubMed 34516308Norgren L, North R, Baumgartner I, Berger JS, Blomster JI, Hiatt WR, Jones WS, Katona BG, Mahaffey KW, Mulder H, Patel MR, Rockhold FW, Fowkes FGR. World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial. Vasc Med. 2022 Feb;27(1):21-29. doi: 10.1177/1358863X211038620. Epub 2021 Sep 13.
- Derived from this study: PubMed 34253048Hiatt WR, Hess CN, Bonaca MP, Kavanagh S, Patel MR, Baumgartner I, Berger JS, Blomster JI, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Fowkes FGR. Ankle-Brachial Index for Risk Stratification in Patients With Symptomatic Peripheral Artery Disease With and Without Prior Lower Extremity Revascularization: Observations From the EUCLID Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e009871. doi: 10.1161/CIRCINTERVENTIONS.120.009871. Epub 2021 Jul 13.
- Derived from this study: PubMed 34082620Hsia J, Kavanagh ST, Hopley CW, Baumgartner I, Berger JS, Fowkes GR, Jones WS, Mahaffey KW, Norgren L, Patel MR, Rockhold F, Blomster J, Katona BG, Hiatt WR, Bonaca MP. Impact of chronic kidney disease on hemoglobin among patients with peripheral artery disease treated with P2Y12 inhibitors: Insights from the EUCLID trial. Vasc Med. 2021 Dec;26(6):608-612. doi: 10.1177/1358863X211017641. Epub 2021 Jun 3.
- Derived from this study: PubMed 33824584Galani J, Mulder H, Rockhold FW, Weissler EH, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Hiatt WR, Katona BG, Norgren L, Mahaffey KW, Quint JK, Patel MR, Jones WS. Association of Chronic Obstructive Pulmonary Disease with Morbidity and Mortality in Patients with Peripheral Artery Disease: Insights from the EUCLID Trial. Int J Chron Obstruct Pulmon Dis. 2021 Mar 29;16:841-851. doi: 10.2147/COPD.S292978. eCollection 2021.
- Derived from this study: PubMed 33176462Kochar A, Mulder H, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Lopes RD, Al-Khalidi HR, Mahaffey KW, Norgren L, Hiatt WR, Patel MR, Jones WS. Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006550. doi: 10.1161/CIRCOUTCOMES.120.006550. Epub 2020 Nov 12.
- Derived from this study: PubMed 32950849Gutierrez JA, Heizer GM, Jones WS, Rockhold FW, Mahaffey KW, Fowkes FGR, Berger JS, Baumgartner I, Held P, Katona BG, Norgren L, Blomster JI, Hiatt WR, Patel MR. CYP2C19 status and risk of major adverse cardiovascular events in peripheral artery disease: Insights from the EUCLID Trial. Am Heart J. 2020 Nov;229:118-120. doi: 10.1016/j.ahj.2020.07.017. Epub 2020 Aug 16. No abstract available.
- Derived from this study: PubMed 32862697Fudim M, Hopley CW, Huang Z, Kavanagh S, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Ostrom C, Patel MR, Jones WS, Hiatt WR. Association of Hypertension and Arterial Blood Pressure on Limb and Cardiovascular Outcomes in Symptomatic Peripheral Artery Disease: The EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006512. doi: 10.1161/CIRCOUTCOMES.120.006512. Epub 2020 Aug 31.
- Derived from this study: PubMed 32615798Long CA, Mulder H, Fowkes FGR, Baumgartner I, Berger JS, Katona BG, Mahaffey KW, Norgren L, Blomster JI, Rockhold FW, Hiatt WR, Patel MR, Jones WS, Nehler MR. Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial. Circ Cardiovasc Qual Outcomes. 2020 Jul;13(7):e006399. doi: 10.1161/CIRCOUTCOMES.119.006399. Epub 2020 Jul 3.
- Derived from this study: PubMed 32057375Haine A, Kavanagh S, Berger JS, Hess CN, Norgren L, Fowkes FGR, Katona BG, Mahaffey KW, Blomster JI, Patel MR, Jones WS, Rockhold FW, Hiatt WR, Baumgartner I; International Steering Committee and Investigators of the EUCLID Trial. Sex-Specific Risks of Major Cardiovascular and Limb Events in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2020 Feb 18;75(6):608-617. doi: 10.1016/j.jacc.2019.11.057.
- Derived from this study: PubMed 31783279Ward R, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Vemulapalli S, Povsic TJ, Mehta R, Hiatt WR, Patel MR, Jones WS. Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. Am Heart J. 2020 Feb;220:51-58. doi: 10.1016/j.ahj.2019.11.007. Epub 2019 Nov 18.
- Redacted 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.
William R Hiatt, MD study chair
University of Colorado School of Medicine
Peter Held, MD study director
AstraZeneca
776 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor and Clopidogrel in people with Peripheral Artery Disease, run by AstraZeneca at 776 sites in 28 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 1 inclusion and 4 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 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 776 sites in United States, Japan, Russia, Spain, Canada and 23 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. 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 30 Oct 2017). 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?
Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke (time frame: From randomization to PACD, an average of 2.5 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 NCT01732822, which also lists 23 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 30 Oct 2017.