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)

This study is currently recruiting participants.

Verified March 2013 by AstraZeneca

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01225562

First received: July 9, 2010

Last updated: March 5, 2013

Last verified: March 2013

History of Changes

Purpose

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).

Condition	Intervention	Phase
Myocardial Infarction Cardiovascular Death Atherothrombosis Stroke	Drug: Ticagrelor 90 mg Drug: Ticagrelor 60 mg Drug: Ticagrelor Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Heart Diseases Vascular Diseases

Drug Information available for: Aspirin Ticagrelor

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. [ Time Frame: Within 1 year to 38 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiovascular death after randomization [ Time Frame: Within 1 year to 38 months ] [ Designated as safety issue: No ]
All-cause mortality after randomization [ Time Frame: Within 1 year to 38 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	21000
Study Start Date:	October 2010
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral Treatment	Drug: Ticagrelor 90 mg Oral dose twice a day
Experimental: 2 Oral Treatment	Drug: Ticagrelor 60 mg Oral dose twice a day
Placebo Comparator: 3 Oral Treatment	Drug: Ticagrelor Placebo Oral dose twice a day

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225562

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

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Locations

United States, Alabama
Research Site	Recruiting
Alexander City, Alabama, United States
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Athens, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
United States, Arizona
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
United States, Arkansas
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
United States, California
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Alhambra, California, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Fountain Valley, California, United States
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La Mesa, California, United States
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Larkspur, California, United States
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Lomita, California, United States
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Los Angeles, California, United States
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Modesto, California, United States
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Newport Beach, California, United States
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Oakland, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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San Marino, California, United States
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Santa Rosa, California, United States
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Ventura, California, United States
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Westlake Village, California, United States
United States, Colorado
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Littleton, Colorado, United States
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Loveland, Colorado, United States
United States, Connecticut
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Hartford, Connecticut, United States
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Stamford, Connecticut, United States
United States, Delaware
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Newark, Delaware, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Florida
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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Coral Springs, Florida, United States
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Crystal River, Florida, United States
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Davie, Florida, United States
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Daytona, Florida, United States
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Daytona Beach, Florida, United States
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Ft Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Largo, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Pannama City, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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Safety Harbor, Florida, United States
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Sarasota, Florida, United States
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South Miami, Florida, United States
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St Petersburg, Florida, United States
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Tallahassee, Florida, United States
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The Villages, Florida, United States
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Wellington, Florida, United States
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West Palm Beach, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Cumming, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Bannockburn, Illinois, United States
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Avon, Indiana, United States
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Elkhart, Indiana, United States
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Fort Wayne, Indiana, United States
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Franklin, Indiana, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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Iowa City, Iowa, United States
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Hutchinson, Kansas, United States
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Crestview Hills, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Covington, Louisiana, United States
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Minden, Louisiana, United States
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New Iberia, Louisiana, United States
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Opelousas, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Auburn, Maine, United States
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Bangor, Maine, United States
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Biddeford, Maine, United States
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S Portland, Maine, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Oxon Hill, Maryland, United States
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Salisbury, Maryland, United States
United States, Massachusetts
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Ayer, Massachusetts, United States
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Boston, Massachusetts, United States
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Haverhill, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
United States, Michigan
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Alpena, Michigan, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Grand Blanc, Michigan, United States
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Grand Rapids, Michigan, United States
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Jackson, Michigan, United States
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Lapeer, Michigan, United States
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Marquette, Michigan, United States
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Petoskey, Michigan, United States
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Pontiac, Michigan, United States
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Saginaw, Michigan, United States
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Southfield, Michigan, United States
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Ypsilanti, Michigan, United States
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Baxter, Minnesota, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Robbinsdale, Minnesota, United States
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St Cloud, Minnesota, United States
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Biloxi, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Kalispell, Montana, United States
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Lincoln, Nebraska, United States
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Papillion, Nebraska, United States
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Reno, Nevada, United States
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Bridgewater, New Jersey, United States
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Elizabeth, New Jersey, United States
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Elmer, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Linden, New Jersey, United States
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Ridgewood, New Jersey, United States
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Somerset, New Jersey, United States
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Albuquerque, New Mexico, United States
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Bronx, New York, United States
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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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Mineola, New York, United States
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New Windsor, New York, United States
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Poughkeepsie, New York, United States
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Saratoga Springs, New York, United States
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Southampton, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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Williamsville, New York, United States
United States, North Carolina
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Asheville, North Carolina, United States
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Cary, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Morganton, North Carolina, United States
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Pinehurst, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Sanford, North Carolina, United States
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Smithfield, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Grand Forks, North Dakota, United States
United States, Ohio
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Akron, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Fairfield, Ohio, United States
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Mansfield, Ohio, United States
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Sandusky, Ohio, United States
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Springfield, Ohio, United States
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Toledo, Ohio, United States
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Youngstown, Ohio, United States
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Zanesville, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Portland, Oregon, United States
United States, Pennsylvania
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Altoona, Pennsylvania, United States
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Beaver, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Chambersburg, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Mine Hill, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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York, Pennsylvania, United States
United States, Rhode Island
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Providence, Rhode Island, United States
United States, South Carolina
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Florence, South Carolina, United States
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Greenville, South Carolina, United States
United States, South Dakota
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Rapid City, South Dakota, United States
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Watertown, South Dakota, United States
United States, Tennessee
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Germantown, Tennessee, United States
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Johnson City, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Oak Ridge, Tennessee, United States
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Tullahoma, Tennessee, United States
United States, Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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Kingwood, Texas, United States
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Mc Allen, Texas, United States
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Mission, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Tyler, Texas, United States
United States, Utah
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Provo, Utah, United States
United States, Virginia
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Charlottesville, Virginia, United States
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Danville, Virginia, United States
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Falls Church, Virginia, United States
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Lynchburg, Virginia, United States
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Manassas, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Winchester, Virginia, United States
United States, Washington
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Bellevue, Washington, United States
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Everett, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
United States, Wisconsin
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Green Bay, Wisconsin, United States
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Wausau, Wisconsin, United States
Canada, Alberta
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Edmonton, Alberta, Canada
Canada, British Columbia
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Kelowna, British Columbia, Canada
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New Westminster, British Columbia, Canada
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Penticton, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
Canada, New Brunswick
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Brampton, Ontario, Canada
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Burlington, Ontario, Canada
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Cambridge, Ontario, Canada
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Cornwall, Ontario, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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North York, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough, Ontario, Canada
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Sudbury, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
Canada, Quebec
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Chicoutimi, Quebec, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Levis, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-charles-borromee, Quebec, Canada
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Saint-georges, Quebec, Canada
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Saint-jerome, Quebec, Canada
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St-lambert, Quebec, Canada
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Terrebonne, Quebec, Canada
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Thetford Mines, Quebec, Canada
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Val D'or, Quebec, Canada
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada
Canada
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Quebec, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01225562 History of Changes
Other Study ID Numbers:	D5132C00001, 2009-017242-30
Study First Received:	July 9, 2010
Last Updated:	March 5, 2013
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Ministry of Social Affairs, Public Health and the Environment Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency Canada: Health Canada Chile: Instituto de Salud Publica de Chile China: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy India: Drugs Controller General of India Italy: Ethics Committee Japan: Ministry of Health, Labor and Welfare Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency Peru: Instituto Nacional de Salud Philippines: Bureau of Food and Drugs Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Pharmacological Committee, Ministry of Health Slovakia: State Institute for Drug Control South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Turkey: Ministry of Health Ukraine: Ministry of Health United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Heart attack
Heart Disease
Acute coronary syndrome
ACS
Cardiovascular Disease

Additional relevant MeSH terms:

Death
Infarction
Myocardial Infarction
Stroke
Cerebral Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013

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