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 |
---|---|
Conditions: | Cardiology, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 50 - 127 |
Updated: | 4/21/2016 |
Start Date: | October 2010 |
End Date: | December 2014 |
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
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).
addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death
from heart disease, heart attack, or stroke).
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
We found this trial at
253
sites
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