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

December 18, 2015 updated by: AstraZeneca

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

21379

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bahia Blanca, Argentina
        • Research Site
      • Buenos Aires, Argentina
        • Research Site
      • Ciudad Autonoma de BA, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Ciudadela, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Coronel Suarez, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Haedo, Argentina
        • Research Site
      • La Plata, Argentina
        • Research Site
      • Mar del Plata, Argentina
        • Research Site
      • Ramos Mejía, Argentina
        • Research Site
      • Rosario, Argentina
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      • Rosario Santa Fe, Argentina
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      • San Luis, Argentina
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      • San Miguel de Tucuman, Argentina
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      • San Nicolas, Argentina
        • Research Site
      • San Salvador de Jujuy, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
      • Santa Fé, Argentina
        • Research Site
      • Tucuman, Argentina
        • Research Site
      • Tucumán, Argentina
        • Research Site
      • Zarate, Argentina
        • Research Site
      • Adelaide, Australia
        • Research Site
      • Ashford, Australia
        • Research Site
      • Auchenflower, Australia
        • Research Site
      • Ballarat, Australia
        • Research Site
      • Bruce, Australia
        • Research Site
      • Chermside, Australia
        • Research Site
      • Clayton, Australia
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      • Concord, Australia
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      • East St Kilda, Australia
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      • Elizabeth Vale, Australia
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      • Epping, Australia
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      • Fremantle, Australia
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      • Geelong, Australia
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      • Gosford, Australia
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      • Greenslopes, Australia
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      • Herston, Australia
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      • Joondalup, Australia
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      • Kingswood, Australia
        • Research Site
      • Kogorah, Australia
        • Research Site
      • Launceston, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
      • Nedlands, Australia
        • Research Site
      • New Lambton Heights, Australia
        • Research Site
      • Richmond, Australia
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      • St Leonards, Australia
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      • Wollongong, Australia
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      • Woodville, Australia
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      • Woolloongabba, Australia
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      • Aalst, Belgium
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      • Antwerpen, Belgium
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      • Bonheiden, Belgium
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      • Bouge, Belgium
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      • Brasschaat, Belgium
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      • Brussels, Belgium
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      • Brussels (Anderlecht), Belgium
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      • Brussels (Jette), Belgium
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      • Brussels (Woluwé-St-Lambert), Belgium
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      • Charleroi, Belgium
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      • Bardejov, Slovakia
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      • Bratislava, Slovakia
        • Research Site
      • Komarno, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Liptovsky Hradok, Slovakia
        • Research Site
      • Liptovsky Mikulas, Slovakia
        • Research Site
      • Martin, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Partizanske, Slovakia
        • Research Site
      • Piestany, Slovakia
        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
      • Alberton, South Africa
        • Research Site
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Centurion, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Gatesville, South Africa
        • Research Site
      • George, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Kempron Park, South Africa
        • Research Site
      • Panorama, South Africa
        • Research Site
      • Parow, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
      • Somerset West, South Africa
        • Research Site
      • Soweto, South Africa
        • Research Site
      • Worcester, South Africa
        • Research Site
      • Almeria, Spain
        • Research Site
      • Aviles, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Bilbao, Spain
        • Research Site
      • Don Benito (Badajoz), Spain
        • Research Site
      • Hospitalet de Llobregat(Barcel, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Majadahonda, Spain
        • Research Site
      • Málaga, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Palma de Mallorca, Spain
        • Research Site
      • Sabadell, Spain
        • Research Site
      • San Sebastian de los Reyes, Spain
        • Research Site
      • Santiago(A Coruña), Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Eksjö, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Jönköping, Sweden
        • Research Site
      • Linkoping, Sweden
        • Research Site
      • Ljungby, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Molndal, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Sundsvall, Sweden
        • Research Site
      • Umea, Sweden
        • Research Site
      • Västerås, Sweden
        • Research Site
      • Örebro, Sweden
        • Research Site
      • Östersund, Sweden
        • Research Site
      • Adana, Turkey
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Malatya, Turkey
        • Research Site
      • Mersin, Turkey
        • Research Site
      • Dnepropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kharkov, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
      • Vinnitsa, Ukraine
        • Research Site
      • Zaporozye, Ukraine
        • Research Site
      • Airdrie, United Kingdom
        • Research Site
      • Antrim, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Blackpool, United Kingdom
        • Research Site
      • Bournemouth, United Kingdom
        • Research Site
      • Brighton, United Kingdom
        • Research Site
      • Bristol, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • East Kilbride, United Kingdom
        • Research Site
      • Ely, United Kingdom
        • Research Site
      • Hastings, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Middlesborough, United Kingdom
        • Research Site
      • Northampton, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Peterborough, United Kingdom
        • Research Site
      • Rotherham, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Swansea, United Kingdom
        • Research Site
      • Torquay, United Kingdom
        • Research Site
      • York, United Kingdom
        • Research Site
    • Alabama
      • Alexander City, Alabama, United States
        • Research Site
      • Athens, Alabama, United States
        • Research Site
      • Birmingham, Alabama, United States
        • Research Site
      • Huntsville, Alabama, United States
        • Research Site
      • Mobile, Alabama, United States
        • Research Site
      • Sheffield, Alabama, United States
        • Research Site
    • Arizona
      • Glendale, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
    • Arkansas
      • Jonesboro, Arkansas, United States
        • Research Site
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Alhambra, California, United States
        • Research Site
      • Anaheim, California, United States
        • Research Site
      • Bakersfield, California, United States
        • Research Site
      • Fountain Valley, California, United States
        • Research Site
      • La Mesa, California, United States
        • Research Site
      • Larkspur, California, United States
        • Research Site
      • Lomita, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Modesto, California, United States
        • Research Site
      • Newport Beach, California, United States
        • Research Site
      • Oakland, California, United States
        • Research Site
      • Oceanside, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Marino, California, United States
        • Research Site
      • Santa Rosa, California, United States
        • Research Site
      • Ventura, California, United States
        • Research Site
      • Westlake Village, California, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
      • Colorado Springs, Colorado, United States
        • Research Site
      • Littleton, Colorado, United States
        • Research Site
      • Loveland, Colorado, United States
        • Research Site
    • Connecticut
      • Hartford, Connecticut, United States
        • Research Site
      • Stamford, Connecticut, United States
        • Research Site
    • Delaware
      • Newark, Delaware, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Clearwater, Florida, United States
        • Research Site
      • Coral Springs, Florida, United States
        • Research Site
      • Crystal River, Florida, United States
        • Research Site
      • Davie, Florida, United States
        • Research Site
      • Daytona, Florida, United States
        • Research Site
      • Daytona Beach, Florida, United States
        • Research Site
      • Ft Lauderdale, Florida, United States
        • Research Site
      • Gainesville, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Hollywood, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Jupiter, Florida, United States
        • Research Site
      • Largo, Florida, United States
        • Research Site
      • Leesburg, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Miami Beach, Florida, United States
        • Research Site
      • Naples, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Pannama City, Florida, United States
        • Research Site
      • Pensacola, Florida, United States
        • Research Site
      • Port Charlotte, Florida, United States
        • Research Site
      • Safety Harbor, Florida, United States
        • Research Site
      • Sarasota, Florida, United States
        • Research Site
      • South Miami, Florida, United States
        • Research Site
      • St Petersburg, Florida, United States
        • Research Site
      • Tallahassee, Florida, United States
        • Research Site
      • The Villages, Florida, United States
        • Research Site
      • Wellington, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Augusta, Georgia, United States
        • Research Site
      • Cumming, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Illinois
      • Aurora, Illinois, United States
        • Research Site
      • Bannockburn, Illinois, United States
        • Research Site
      • Chicago, Illinois, United States
        • Research Site
      • Melrose Park, Illinois, United States
        • Research Site
      • Normal, Illinois, United States
        • Research Site
      • Rock Island, Illinois, United States
        • Research Site
    • Indiana
      • Avon, Indiana, United States
        • Research Site
      • Elkhart, Indiana, United States
        • Research Site
      • Fort Wayne, Indiana, United States
        • Research Site
      • Franklin, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
      • Muncie, Indiana, United States
        • Research Site
      • Munster, Indiana, United States
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States
        • Research Site
    • Kansas
      • Hutchinson, Kansas, United States
        • Research Site
    • Kentucky
      • Crestview Hills, Kentucky, United States
        • Research Site
      • Lexington, Kentucky, United States
        • Research Site
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Alexandria, Louisiana, United States
        • Research Site
      • Covington, Louisiana, United States
        • Research Site
      • Minden, Louisiana, United States
        • Research Site
      • New Iberia, Louisiana, United States
        • Research Site
      • Opelousas, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
      • Slidell, Louisiana, United States
        • Research Site
    • Maine
      • Auburn, Maine, United States
        • Research Site
      • Bangor, Maine, United States
        • Research Site
      • Biddeford, Maine, United States
        • Research Site
      • S Portland, Maine, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Columbia, Maryland, United States
        • Research Site
      • Oxon Hill, Maryland, United States
        • Research Site
      • Salisbury, Maryland, United States
        • Research Site
    • Massachusetts
      • Ayer, Massachusetts, United States
        • Research Site
      • Boston, Massachusetts, United States
        • Research Site
      • Burlington, Massachusetts, United States
        • Research Site
      • Haverhill, Massachusetts, United States
        • Research Site
      • North Dartmouth, Massachusetts, United States
        • Research Site
    • Michigan
      • Alpena, Michigan, United States
        • Research Site
      • Ann Arbor, Michigan, United States
        • Research Site
      • Detroit, Michigan, United States
        • Research Site
      • Flint, Michigan, United States
        • Research Site
      • Grand Blanc, Michigan, United States
        • Research Site
      • Grand Rapids, Michigan, United States
        • Research Site
      • Jackson, Michigan, United States
        • Research Site
      • Lapeer, Michigan, United States
        • Research Site
      • Marquette, Michigan, United States
        • Research Site
      • Petoskey, Michigan, United States
        • Research Site
      • Pontiac, Michigan, United States
        • Research Site
      • Saginaw, Michigan, United States
        • Research Site
      • Southfield, Michigan, United States
        • Research Site
      • Ypsilanti, Michigan, United States
        • Research Site
    • Minnesota
      • Baxter, Minnesota, United States
        • Research Site
      • Duluth, Minnesota, United States
        • Research Site
      • Minneapolis, Minnesota, United States
        • Research Site
      • Robbinsdale, Minnesota, United States
        • Research Site
      • St Cloud, Minnesota, United States
        • Research Site
    • Mississippi
      • Biloxi, Mississippi, United States
        • Research Site
      • Tupelo, Mississippi, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • Kansas City, Missouri, United States
        • Research Site
      • St Louis, Missouri, United States
        • Research Site
    • Montana
      • Billings, Montana, United States
        • Research Site
      • Great Falls, Montana, United States
        • Research Site
      • Kalispell, Montana, United States
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Research Site
      • Omaha, Nebraska, United States
        • Research Site
      • Papillion, Nebraska, United States
        • Research Site
    • Nevada
      • Reno, Nevada, United States
        • Research Site
    • New Jersey
      • Bridgewater, New Jersey, United States
        • Research Site
      • Elizabeth, New Jersey, United States
        • Research Site
      • Elmer, New Jersey, United States
        • Research Site
      • Haddon Heights, New Jersey, United States
        • Research Site
      • Linden, New Jersey, United States
        • Research Site
      • Mine Hill, New Jersey, United States
        • Research Site
      • Newark, New Jersey, United States
        • Research Site
      • Ridgewood, New Jersey, United States
        • Research Site
      • Somerset, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
      • Buffalo, New York, United States
        • Research Site
      • Cortlandt Manor, New York, United States
        • Research Site
      • Mineola, New York, United States
        • Research Site
      • New Windsor, New York, United States
        • Research Site
      • Poughkeepsie, New York, United States
        • Research Site
      • Saratoga Springs, New York, United States
        • Research Site
      • Southampton, New York, United States
        • Research Site
      • Stony Brook, New York, United States
        • Research Site
      • Williamsville, New York, United States
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States
        • Research Site
      • Burlington, North Carolina, United States
        • Research Site
      • Cary, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
      • Hickory, North Carolina, United States
        • Research Site
      • Morganton, North Carolina, United States
        • Research Site
      • Pinehurst, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
      • Rocky Mount, North Carolina, United States
        • Research Site
      • Sanford, North Carolina, United States
        • Research Site
      • Smithfield, North Carolina, United States
        • Research Site
      • Statesville, North Carolina, United States
        • Research Site
      • Wilmington, North Carolina, United States
        • Research Site
    • North Dakota
      • Grand Forks, North Dakota, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
      • Canton, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
      • Fairfield, Ohio, United States
        • Research Site
      • Mansfield, Ohio, United States
        • Research Site
      • Sandusky, Ohio, United States
        • Research Site
      • Springfield, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
      • Youngstown, Ohio, United States
        • Research Site
      • Zanesville, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
      • Tulsa, Oklahoma, United States
        • Research Site
    • Oregon
      • Bend, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Research Site
      • Beaver, Pennsylvania, United States
        • Research Site
      • Bethlehem, Pennsylvania, United States
        • Research Site
      • Chambersburg, Pennsylvania, United States
        • Research Site
      • Doylestown, Pennsylvania, United States
        • Research Site
      • Erie, Pennsylvania, United States
        • Research Site
      • Johnstown, Pennsylvania, United States
        • Research Site
      • Lancaster, Pennsylvania, United States
        • Research Site
      • Langhorne, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Scranton, Pennsylvania, United States
        • Research Site
      • Sellersville, Pennsylvania, United States
        • Research Site
      • West Chester, Pennsylvania, United States
        • Research Site
      • York, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States
        • Research Site
      • Charleston, South Carolina, United States
        • Research Site
      • Florence, South Carolina, United States
        • Research Site
      • Greenville, South Carolina, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
      • Watertown, South Dakota, United States
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States
        • Research Site
      • Jackson, Tennessee, United States
        • Research Site
      • Knoxville, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
      • Oak Ridge, Tennessee, United States
        • Research Site
      • Tullahoma, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Fort Worth, Texas, United States
        • Research Site
      • Georgetown, Texas, United States
        • Research Site
      • Grapevine, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Katy, Texas, United States
        • Research Site
      • Kingwood, Texas, United States
        • Research Site
      • MC Allen, Texas, United States
        • Research Site
      • McAllen, Texas, United States
        • Research Site
      • Plano, Texas, United States
        • Research Site
      • Round Rock, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Tomball, Texas, United States
        • Research Site
      • Tyler, Texas, United States
        • Research Site
      • Victoria, Texas, United States
        • Research Site
    • Utah
      • Provo, Utah, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Virginia
      • Alexandria, Virginia, United States
        • Research Site
      • Charlottesville, Virginia, United States
        • Research Site
      • Danville, Virginia, United States
        • Research Site
      • Falls Church, Virginia, United States
        • Research Site
      • Lynchburg, Virginia, United States
        • Research Site
      • Manassas, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
      • Winchester, Virginia, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Everett, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
    • Wisconsin
      • Green Bay, Wisconsin, United States
        • Research Site
      • Wausau, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
  • Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
  • Persons with known bleeding disorders
  • Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
  • Persons with a history of ischemic stroke
  • Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
  • Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
  • Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
  • Persons with known severe liver disease
  • Persons with kidney failure requiring dialysis
  • Persons with life expectancy < 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Oral Treatment
Oral dose twice a day
Experimental: 2
Oral Treatment
Oral dose twice a day
Placebo Comparator: 3
Oral Treatment
Oral dose twice a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Eugene Braunwald, MD, TIMI Study Group
  • Principal Investigator: Marc Sabatine, MD, MPh, TIMI Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

December 18, 2015

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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