ACUTE CORONARY SYNDROMES,NOS
Conditions
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent; 2) Recent (=7 days) Acute Coronary Syndrome with: a) symptoms of myocardial ischemia (chest pain, dyspnea, etc.) lasting a total of at least 10 minutes (see Section 7.2.1) And either b) elevation in cardiac biomarkers (troponin T or I or creatine kinase-MB) above the upper limit of normal or c) dynamic ST segment deviation [depression or elevation of =0.1 mV (1.0 mm)] 3) Clinically stable, receiving standard care for ACS, including antiplatelet therapy [acetylsalicylic acid (ASA) = 165 mg/day, with or without clopidogrel 75 mg/day, based on the choice of the treating physician] 4) Either unknown coronary anatomy or angiographic evidence of atherosclerotic plaque in any major coronary artery, significant branch, or coronary bypass graft 5) Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile), and men, ages 18 (or legal age of consent) to 90. Plus 1 or more additional risk characteristics from the following: 1) Age = 65 years 2) Both elevation in cardiac markers and dynamic ST deviation = 1 mm 3) Diabetes mellitus 4) MI within the last 12 months (other than qualifying event) 5) Cerebrovascular disease [prior (>3 months) ischemic stroke; prior TIA or asymptomatic >70% stenosis in either internal carotid artery] 6) Peripheral vascular disease (claudication with decreased pulses, a prior peripheral revascularization procedure, or an ABI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Women of child bearing potential: a. Any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal. b. Women who are pregnant or breastfeeding. c. Women with a positive pregnancy test on enrollment or prior to study drug administration. 2) Scheduled/planned cardiac catheterization, PCI, CABG or other invasive procedure planned in the 26 weeks following randomization; 3) Persistent severe hypertension, defined as systolic blood pressure of =180 mm Hg or diastolic pressure of =110 mm Hg 4) Severe renal dysfunction (calculated creatinine clearance 3 months) daily NSAID or chronic high dose ASA use (>325 mg/day); *Plus exclusion criteria 24, strong CYP3A4 inhibitors 16) Below the legal lower age (country specific); 17) Participation in another investigational drug or device study within the prior 30 days; 18) Subjects who participated previously in this or any other study involving BMS-562247; 19) Any condition which, in the opinion of the Investigator, may pose a significant hazard to the subject if he or she is enrolled in the trial; 20) Subject inability to follow the protocol; 21) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. 22) Netherlands Specific Exclusion Criteria 23) Active hepatobiliary disease, based on an ALT or AST > 2X ULN or a Total Bilirubin = 1.5X ULN (unless an alternative causative factor [e.g., Gilbert’s syndrome] is identified). 24) Need for ongoing treatment with known strong inhibitors of CYP3A4, for example: azole antifungals (itraconazole and ketoconazole), macrolide antibiotics (clarithromycin and telithromycin), protease inhibitors (ritonavir, indinavir, nelfinavir, atazanavir, and saquinavir), and nefazadone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate 4 doses of apixaban as compared to placebo over a 26 week treatment period in selected subjects with recent (=7 days) Acute Coronary Syndrome (ACS) for safety (bleeding) and to determine the optimal dose and regimen of apixaban for use in Phase 3 ACS treatment.;Secondary Objective: The secondary safety objectives are: • to evaluate the incidence of cardiovascular and all-cause death, non-fatal myocardial infarction, severe recurrent ischemia and non-hemorrhagic stroke during the 30 days after discontinuation of therapy • to assess the incidence of adverse events and abnormal clinical laboratory test results. The secondary efficacy objectives are: • to evaluate the incidence of the composite of cardiovascular death, non-fatal myocardial infarction, severe recurrent ischemia and non-hemorrhagic stroke through Week 26. • to evaluate the incidence of the composite of all-cause death, non-fatal myocardial infarction, severe recurrent ischemia and non-hemorrhagic stroke through Week 26.;Primary end point(s): Efficacy Analyses The primary objective of this study is related to safety. There is no primary efficacy outcome. Secondary Efficacy outcomes are: • the composite of cardiovascular death, non-fatal myocardial infarction, severe recurrent ischemia and non-hemorrhagic stroke occurring through Week 26 • the composite of all-cause death, non-fatal myocardial infarction, severe recurrent ischemia and non-hemorrhagic stroke occurring through Week 26. • the composite of all-cause death and myocardial infarction occurring through Week 26 • the composite of all-cause death and non-hemorrhagic stroke occurring through Week 26 • all-cause death occurring through Week 26 • cardiovascular death occurring through Week 26 • the composite of all-cause death and severe recurrent ischemia occurring through Week 26. Safety Analysis The primary safety outcome for this trial is the composite of major bleeding and clin | — |
Countries
Austria, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed