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TRA2P
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects with a history of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherthrombotic Ischemic Events (TRA2°P – TIMI 50)
Study Phase III
Purpose
The study is designed to determine whether SCH 530348, when added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel) in patient with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without SCH 530348 in preventing heart attack and stroke.
The is also designed to assess risk of bleeding with SCH 530348 added to the standard of care versus the standard of care alone.
The study population will include those who meet the following inclusion/exclusion criteria, some of which are:
Inclusion Criteria
- men & women at least 18 years old with evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems by one or more of the following:
- history of MI
- history of Ischemic stroke
- history of Peripheral arterial disease
Exclusion Criteria
- history of intracranial hemorrhage or a of CNS surgery, tumor, or aneurysm
- any bleeding disorder or abnormality
- sustained severe platelet count <100,000/cumm
- planned or ongoing treatment with a blood thinning medication
- pregnancy
- any significant medical or physiological conditions or abnormality that could put the subject at increased risk or limit the subject’s ability to participate for the duration of the study
To inquire if you are eligible for this study or hear more about it, please contact:
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