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"


Phase 3 Results

Eligibility 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