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

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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).


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
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