Clinical Research Details
Title:
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 Atherothrombotic Ischemic Events
Purpose:
The purpose of this study is to test the safety and effectiveness of SCH 530348 when used with standard medications. Complications of atherosclerosis can occur when a blood clot forms rapidly in an artery causing a more severe blockage and decrease in blood flow. The study drug is an antiplatelet medication.
Study Number:
201062
Number of Patients:
20000
Elgibility:
Inclusion Criteria:
1. Participants must be at least 18 years old at the screening visit.
2. Participants must have evidence or a history of atherosclerosis involving the coronary, cerebral or peripheral vascular systems.
3. A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specific medication and for two months after stopping the medication.
Exclusion Criteria:
1. Participants must be clinically unstable at time of enrollment.
2. Participants must not have any planned coronary revascularization or
peripheral intervention.
3. Participants must not be taking or anticipate treatment with coumadin, oral factor Xa inhibitor or oral direct thrombin inhibitor after enrollment.
4. Participants must not be taking concurrent or anticipated treatment with a potent inducer or inhibitor of CYP3A4 isoenzymes.
5. Participants must not have a history of bleeding diathesis or evidence of active abnormal bleeding within 30 days before enrollment.
6. Participants must not have a history of intracranial hemorrhage, intracranial or spinal cord surgery or a central nervous system tumor or aneurysm,
7. Participants must not have documented sustained severe hypertension (SBP >200) or diastolic blood pressure (>110) at enrollment or within the previous 30 days.
8. Participants must not have severe valvular heart disease.
9. Participants must not have known platelet count <100,000/mm3 within 30 days before enrollment.
10. Participants with active hepatobiliary disease or unexplained persistent increase in serum ALT or AST activity to two times or more the upper limit of the reference range.
11. Participants with any serious illness or any condition that the investigator feels would pose a significant hazard to the subject if investigational therapy were initiated or would limit the prognosis of the subject, regardless of investigational therapy.
12. Participants with any serious medical comorbidity (e.g., active malignancy) such that the subject’s life expectancy is <24 months.
13. Participants who had previous participation in the current study.
14. Participants with current participation in any other study of
investigational therapy or participation in such a study within
the past 30 days.
15. Participants with known hypersensitivity to any component of the current investigational product.
Treatment:
In this study there will be two groups: one active medication group (receiving SCH 530348 study drug in addition to current therapy, if any) and one control group (receiving placebo in addition to current therapy, if any). Your assignment to one of the two groups will be done randomly by a computer (after a phone call to a central system, you will be assigned to one of two treatment groups like a flip of a coin). There is a 50 percent chance that you will be randomly assigned to the active medication group and a 50 percent chance that you will be assigned to the placebo group.
Principal Investigator:
Enrollment Phone:
(708) 216-6638