Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Myocardial Infarction
Cardiovascular Death
Eligibility:
All Genders
50-130 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
21379 Patients enrolled
Trial Details
Trial ID
NCT01225562
Start Date
October 1 2010
End Date
December 1 2014
Last Update
January 25 2016
Active Locations (827)
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1
Research Site
Alexander City, Alabama, United States
2
Research Site
Athens, Alabama, United States
3
Research Site
Birmingham, Alabama, United States
4
Research Site
Huntsville, Alabama, United States