Primary Investigator: Kul Aggarwal, MD
Study Coordinator: Alisa Lau-Sieckman, RN
Status: Closed to enrollment; follow-up continues
Study Title: A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SCH530348 in additional to standard of care in subjects with acute coronary syndrome: Thrombin receptor antagonist for clinical event reduction in acute coronary syndrome (ACS)
Purpose: The primary objective is to evaluate the hypothesis that SCH530348 added to standard of care will reduce the incidence of atherothrombotic ischemic events relative to standard of care alone, as measured by the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization and urgent coronary revascularization.
1. Subject must be 18 years of age or older, and may be of either sex and of any race.
2. Subject must have a current clinical manifestation of NSTEACS according to the following three criteria:
a. History of cardiac-ischemia-related symptoms of at least 10 minutes duration 24 hours prior to hospital presentation
b. Any one (or more) of the following two criteria:
i. Concurrent biomarker evidence of elevated troponin I or troponin T greater than the stated upper limit of normal (ULN) at the study site, OR creatine kinase-myocardial band (CK-MB) greater than the ULN at the study site.
ii. Concurrent electrocardiographic evidence such as electrocardiogram (ECG) changes comprising new or presumably new ST-segment depression 0.1 mV or transient (<30 minutes) ST-segment elevation 0.1 mV (1 mm) in at least two contiguous leads
c. any one (or more) of the following four criteria
i. age greater than 55 years.
ii. documented prior history of MI or coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]).
iii. diabetes (documented use of insulin or oral hypoglycemic[s]).
iv. peripheral arterial disease (PAD) as indicated by a history of intermittent claudication and either
(a) an ankle/brachial index (ABI) of <0.85,
(b) amputation, peripheral bypass, or peripheral angioplasty of the extremities secondary to ischemia.
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-specified medication, and for two months after stopping the medication.
4. A woman of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
1. Concurrent or anticipated treatment with warfarin (or derivatives, e.g., phenprocoumon [but see notes in text for exceptions]), oral factor Xa inhibitor, or oral direct thrombin inhibitor after enrollment.
2. Concurrent or anticipated treatment with a potent inducer (e.g., rifampin) or potent inhibitor (e.g., ketoconazole, erythromycin) of CYP3A4 isoenzymes (but see note in text for exceptions).
3. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment.
4. History at any time of intracranial hemorrhage, intracranial or spinal cord surgery, or a central nervous system tumor or aneurysm.
5. Documented sustained severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) at enrollment or within the previous 10 days.
6. Devere valvular heart disease, as defined by the American College of Cardiology/American Heart Association.
7. History within two weeks prior to enrollment of major surgery other than mentioned above or of ischemic (presumed thrombotic) stroke.
8. Known platelet count <100,000/mm3 at time of enrollment or within 24 hours prior to enrollment.
9. Known active hepatobiliary disease, or known unexplained persistent increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to two times or more the upper limit of the reference range (upper limit of "normal" [?2xULN]) within 30 days before enrollment.
10. Any serious illness or any condition that the investigator feels would
(a) pose a significant hazard to the subject if investigational therapy were initiated,
(b) would limit the prognosis of the subject, regardless of investigational therapy.
11. Any serious medical comorbidity (e.g., active malignancy) such that the subject's life expectancy is <24 months.
12. Previous participation in the current study.
13. Current participation in any other study of investigational therapy, or participation in such a study within the last 30 days.
14. Known hypersensitivity to any component of the current investigational product.
15. Subject is a woman who is breast-feeding, pregnant, or who intends to become pregnant.
16. Subject is part of the staff personnel directly involved with this study, or is a family member of the investigational staff.
1. Call Alisa Lau-Sieckman (beeper: 573-443-9259) and/or on-call research nurse (on-call beeper 573-499-8084) or Dr. Aggarwal if subject is admitted to the hospital or for any questions.
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