Documented coronary artery disease, postischemic cerebrovascular disease or peripheral artery disease. MedDRA version: 9.1 Level: LLT Classification code 10043634 Term: Thrombosis prophylaxis
Conditions
Interventions
Product Name: SCH 530348 bisulfate Tablet
Product Code: SCH 530348
Pharmaceutical Form: Tablet
CAS Number: 705260-08-8
Concentration uni
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject may be of either sex and any race, and must be at least 18 years old. 2. Subject must have evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems as follows: a. CAD as indicated by a history of presumed spontaneous MI [hospitalized with final diagnosis of MI, excluding periprocedural or definite secondary MI (eg, due to profound anemia or hypertensive emergency, troponin increase in sepsis)] = 2 weeks but = 12 months prior. b. ischemic (presumed thrombotic) CVD as indicated by a history of ischemic stroke (hospitalized with final diagnosis of nonhemorrhagic stroke) =2 weeks but = 12 months prior. c. PAD as indicated by a history of intermittent claudication and I. an ankle/brachial index of (ABI) of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically unstable at the time of enrollment. 2. Any planned coronary revascularization or peripheral intervention. 3. Concurrent or anticipated treatment with warfarin (or derivatives, eg, phenprocoumon), oral factor Xa inhibitor, or oral direct thrombin inhibitor after enrollment. (Note 1: If a subject is taking warfarin during determination of eligibility, and the investigator is willing to stop the subject's treatment with warfarin immediately, and the subject is not otherwise disqualified from participation, then the subject may receive randomized assignment of study drug)(Note 2: A subject who was not using warfarin/derivatives and for whom use was not anticipated, but who subsequently requires warfarin/derivatives after randomized assignment of study drug may continue treatment with warfarin/derivatives and randomized study drug, except when aspirin /thienopyridine/warfarin concurrent therapy is needed & thienopyridine cannot be discontinued). 4. Concurrent or anticipated treatment with a potent inducer (eg, rifampin) or potent inhibitor (eg, ketoconazole, erythromycin) of CYP3A4 isoenzymes (detailed list will be supplied to investigator). (Note: A subject who was not using a potent 3A4 inducer or potent inhibitor and/or for whom such therapy was not anticipated, but requires such therapy after randomization may receive such therapy as follows: a. potent 3A4 inducer - continue study drug until therapy with inducer ends or until inducer therapy extends beyond 4 weeks, then discontinue study drug; b. potent 3A4 inhibitor - interrupt study drug treatment until inhibitor therapy ends or until inhibitor therapy extends beyond 4 weeks, then discontinue study drug). 5. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment. 6. History at any time of intracranial hemorrhage, intracranial or spinal cord surgery, or a central nervous system tumor or aneurysm. 7. Documented sustained severe hypertension (systolic blood pressure >200mmHg or diastolic blood pressure >110mmHg) at enrollment or within the previous 10 days. 8. Severe valvular heart disease 9. History within 2 weeks prior to enrollment of major surgery other than mentioned above or of ischemic (presumed thrombotic) stroke. 10. Known platelet count <100,000/mm3 within 30 days before enrollment. 11. Active hepatobiliary disease or 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]. 12. Any serious illness or any condition that the investigator feels would (a) pose a significant hazard to the subject if investigational therapy were initiated, or (b) would limit the prognosis of the subject, regardless of investigational therapy. 13. Any serious medical comorbidity (eg, active malignancy) such that the subject's life expectancy is <24 months. 14. Previous participation in the current study. 15. Current participation in any other study of investigational therapy, or participation in such a study within the last 30 days. 16. Known hypersensitivity to any component of the current i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the hypothesis that SCH 530348 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 (CV) death, myocardial infarction (MI), stroke, and urgent coronary revascularization (revasc).; Secondary Objective: Key secondary obj: evaluate benefit with respect to the composite of CV death, MI, & stroke. Other secondary efficacy obj: eval incidence of: 1. all-cause death, MI, stroke & urgent coronary revasc 2. CV death & MI 3. CV death, MI, stroke, urgent coronary revasc, or urgent hospitalization for vascular cause of ischemic nature 4. all-cause death, MI, stroke, any revasc (incl amputation for ischemic limb) 5. CV death, MI, stroke, revasc (incl amputation for ischemic limb) or urgent hospitalization for vascular cause of ischemic nature 6. individual components of composite primary efficacy endpt: CV death, MI, stroke, urgent coronary revasc 7. all-cause death. Safety obj: eval incidence of: 1. composite of moderate & severe bleeding events according to GUSTO 2. clinically significant bleeding defined as TIMI major/minor bleeding, bleeding that requires unplanned medical or surgical treatment or lab eval even if it does not meet criteria for TIMI major/minor bleeding. ;Primary end point(s): 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. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed