None listed
Conditions
Interventions
Oral apixaban 5 mg or 2.5 mg tablets given BID or oral vitamin K antagonist (VKA) tablets given once daily (titrated for INR goal of 2.0 to 3.0) for the 6 month treatment period . Blinded 81 mg aspiri
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Signed Written Informed Consent a) Subjects will be required to provide a written informed consent. 2. Target Population a) Adults 18 years of age or older with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. b) Must have had an acute coronary syndrome (ST-elevation myocardial infarction [STEMI] or non-ST-elevation myocardial infarction [NSTEMI]) or percutaneous coronary intervention with a stent within the prior 14 days c) Planned use of antiplatelet agents for at least 6 months. 3. Subject Re-enrollment: a) This study does permit the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (screen failure). 4. Age and Reproductive Status a) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. b) Women must not be breastfeeding c) WOCBP must agree to use effective contraception for the duration of treatment with study drugs plus i. 33 days for patients on apixaban ii. 40 days for patients on VKA d) Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in this section.
Exclusion criteria
Exclusion criteria: 3.3.2 Exclusion Criteria 1. Target Disease Exceptions a) Conditions other than non-valvular atrial fibrillation that require chronic anticoagulation (eg, prosthetic [tissue or mechanical] heart valve) 2. Medical History and Concurrent Diseases a) Severe renal insufficiency (serum creatinine > 2.5 [133 micromol/L] or a calculated creatinine clearance < 30 mL/min b) Patients with any history of intracranial hemorrhage c) Any contraindications to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin d) Patients who have or will undergo coronary arterial bypass graft (CABG) for their index ACS event e) Women who are pregnant, breastfeeding, or of childbearing potential and unable to use an acceptable method of birth control f) Women who are of childbearing potential or breastfeeding 3. Physical and Laboratory Test Findings a) Patients with known ongoing bleeding b) Patients with known coagulopathies 4. Allergies and Adverse Drug Reaction Known allergies or sensitivities to apixaban, VKA, aspirin, or to intended P2Y12 antagonist. 5. Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness c) Subjects who would have compromised ability to comply with study therapy or follow up visits 6. Current employees of Pfizer, Bristol-Myers Squibb, or PPD are excluded from participation, as well as their spouses and dependent children.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Germany, Hungary, Israel, Italy, Korea South, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactElizabeth Principe
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed