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

Completed · Phase 3 · Has a placebo group

Conditions studied: Myocardial Infarction, Cardiovascular Death, Atherothrombosis, Stroke

In brief

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).

Key facts

Study ID

NCT01225562

Run by

AstraZeneca

People needed

21379

Starts

2010-10-01

Expected to finish

2014-12-01

Last updated by the study team

2016-01-25

Who can join

Age: 50 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — Glendale, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — 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 — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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