Health Condition 1: null- Atrial Fibrillation, Not Caused by a Heart Valve Problem
Conditions
Interventions
Intervention1: Apixaban: 5 mg or 2.5 mg Apixaban tablets orally twice per day for 6 months treatment period
Control Intervention1: Active Comparator: Vitamin K Antagonist: Warfarin tablets
1mg and 5mg
Sponsors
BristolMyers Squibb Research and Development
Eligibility
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) Males and females 18 years of age (or age of majority) 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], non-ST-elevation myocardial infarction [NSTEMI], or unstable angina), within the prior 14 days c) Planned use of an approved P2Y12 inhibitor 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. Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Target Disease Exceptions a) Conditions other than non-valvular atrial fibrillation that require chronic anticoagulation (eg, mechanical heart valve) 2. Medical History and Concurrent Diseases a) Severe renal insufficiency (serum creatinine > 2.5 [221 micromol/L] or a calculated creatinine clearance 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 3. Physical and Laboratory Test Findings a) Patients with known ongoing bleeding b) Patients with known coagulopathies 4. Allergies and Adverse Drug Reaction a) 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 d) Subjects who are participating in other interventional clinical trials of other drugs or unapproved devices. 6. Current employees of Pfizer, Bristol-Myers Squibb, or PPD are excluded from participation, as well as their spouses and dependent children. Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and that the results of the study can be used. It is imperative that subjects fully meet all inclusion criteria and no exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major or Clinically Relevant Non-Major (CRNM) bleeding during the treatment period between Apixaban and VKA time to first occurrence of ISTH major or CRNM bleeding during the time the patient is taking the medicine which is 6 months Timepoint: Approximately 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| First re-hospitalization for any cause between Apixaban versus VKA time to first occurrence during the time the patient is taking the medicine which is 6 monthsTimepoint: Approximately 6 months;First re-hospitalization for any cause between aspirin versus placebo time to first occurrence during the time the patient is taking the medicine which is 6 monthsTimepoint: Approximately 6 months;Superiority on major and CRNM bleeding between Apixaban versus VKA time to first occurrence during the time the patient is taking the medicine which is 6 monthsTimepoint: Approximately 6 months;The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization) between Apixaban versus VKA time to first occurrence during the time the patient is taking the medicine which is 6 monthsTimepoint: Approximately 6 months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States of America
Contacts
Public ContactShilpi Sinha
Bristol-Myers Squibb-Regional Clinical Operations
Outcome results
None listed