A Phase 2, Placebo-Controlled, Randomized, Double-Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban In Patients with a Recent Acute Coronary Syndrome - APPRAISE-1
- Conditions
- Acute coronary syndromesMedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome
- Registration Number
- EUCTR2005-004338-42-IT
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1900
1 Signed written informed consent Target population 2 Recent 8804;7 days Acute Coronary Syndrome with a symptoms of myocardial ischemia chest pain, dyspnea, etc. lasting a total of at least 10 minutes 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 8805;0.1 mV 1.0 mm 3 Clinically stable, receiving standard care for ACS, including antiplatelet therapy acetylsalicylic acid ASA 8804; 165 mg/day, with or without clopidogrel 75 mg/day, based on the choice of the treating physician 4 Either unknown coronary anatomy or 50 stenosis in at least one major epicardial coronary artery Age and Sex 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. Women are considered surgically sterile only if they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy. Women are considered postmenopausal only if they have had amenorrhea for 8805; 12 consecutive months, or for women on hormone replacement therapy HRT , if they have a documented serum follicle stimulating hormone FSH level 35 mIU/mL. Plus 1 or more additional risk characteristics from the following 1 Age 8805; 65 years 2 Both elevation in cardiac markers and dynamic ST deviation 8805; 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 0.9 7 Prior symptomatic CHF or a left ventricular ejection fraction 40 8 Non-revascularized multivessel CAD 8805;2 vessels 9 Mild or moderate renal insufficiency calculated CrCl 30-90 mL/min
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Sex and Reproductive Status 1 Women of child bearing potential a. Any female who has experienced menarche and who has not undergone successful surgical sterilization hysterectomy, bilateral tubal ligation or bilateral oophorectomy or is not postmenopausal defined as amenorrhea 12 consecutive months; or women on hormone replacement therapy HRT with documented serum follicle stimulating hormone FSH level 35 mIU/mL . Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods diaphragm, condoms, spermicides to prevent pregnancy or practicing abstinence or where partner is sterile e.g., vasectomy , should be considered to be of child bearing potential. b. Women who are pregnant or breastfeeding. c. Women with a positive pregnancy test on enrollment or prior to study drug administration. Target Disease Exceptions 2 Scheduled/planned cardiac catheterization, PCI, CABG or other invasive procedure planned in the 26 weeks following randomization Medical History and Concurrent Diseases 3 Persistent severe hypertension, defined as systolic blood pressure of 8805;180 mm Hg or diastolic pressure of 8805;110 mm Hg 4 Severe renal dysfunction calculated creatinine clearance 30 mL/min 5 Active bleeding or at high risk for bleeding e.g., cirrhosis of the liver, any history of intracranial hemorrhage 6 Known coagulopathy 7 Acute pericarditis or pericardial effusion 8 Recent stroke within the last 3 months 9 Prior New York Heart Association NYHA Class IV Physical and Laboratory Test Findings 10 Platelet count 8804;100,000/mm3 11 Hemoglobin 10 g/dL12 Hematocrit 30 Allergies and Adverse Drug Reactions 13 Inability to take aspirin due to allergy or intolerance Prohibited Therapies and/or Medications 14 Need for ongoing treatment with a parenteral or oral anticoagulant see Section 6.4.1 , eg, subjects with mechanical valves, warfarin eligible atrial fibrillation 15 Need for chronic 3 months daily NSAID or chronic high dose ASA use 325 mg/day Other Exclusion Criteria 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method