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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ticagrelor

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