Status:
Enrollment is complete. Follow-up is ongoing.
Purpose:
To determine whether SCH 530348, when added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel) in patients 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 study is also designed to assess risk of bleeding with SCH 530348 added to the standard of care versus the standard of care alone.
Interventions:
Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
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SCH-530-348
is a thrombin receptor (PAR-1) antagonist based on the natural product himbacine.
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Location(s):
United States, Argentina, Australia,
Austria, Belgium,
Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Isreal, Italy, Japan, Malaysia, Netherlands,
New Zealand, Norway, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden,
Switzerland, United Kingdom
Year Started:
2007
Design:
Interventional, Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
Men and 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 myocardial infarction (heart attack);
history of ischemic stroke (stroke due to a blocked artery);
or history of peripheral arterial disease.
Exclusion Criteria
History of intracranial hemorrhage or of CNS surgery, tumor, or aneurysm; any bleeding disorder or abnormality; sustained severe hypertension or valvular heart disease; current or recent platelet count <100,000/cumm; planned or ongoing treatment with a blood thinning medication; pregnancy; any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study.
Patient Involvement:
Patient will be randomized to one of two arms: 1) placebo matching tablet daily for at least 1 year or SCH-530-348 2.5-mg tablet daily for at least 1 year.
Primary Outcome:
The primary efficacy endpoint of the study is the first occurrence of any component of the composite of cardiovascular death, MI, stroke, and urgent coronary revascularization
Secondary Outcome:
The key secondary efficacy endpoint is the first occurrence of any component of the composite of cardiovascular death, MI, and stroke.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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Trials
Directories