A non-blinded (i.e., open-label), randomized clinical trial to evaluate the safety of Apixaban (Eliquis®=BMS oral anticoagulant) vs. Coumadin [=vitamin K antagonist (VKA)} and blinded Aspirin vs. Aspirin Placebo in patients with atrial fibrillation (not related to a heart valve problem or nonvalvular AF = NVAF) and heart attacks (i.e., ACS = Acute Coronary Syndrome) with a coronary stent placement (PCI = percutaneous coronary intervention) OR after having elective PCI for chest pain.
- Conditions
- Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary InterventionMedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0 Level: PT Classification code 10065608 Term: Percutaneous coronary intervention System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-002004-24-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 4600
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 for at least 6
months AND
b) An acute coronary syndrome (ST-elevation myocardial infarction
[STEMI], non-ST-elevation myocardial infarction [NSTEMI], or unstable
angina), within
the prior 14 days with planned use of an approved P2Y12 inhibitor for at
least 6 months
AND/OR
c)PCI (with or without stents) within the prior 14 days with planned use
of an approved P2Y12 inhibitor for at least 6 months.
(If both an ACS event and an elective PCI occur within the same 14 day
period, the investigator has the option to define the index event for the
randomization to the interactive voice/web response system. It is
recommended to choose the most recent event as the index event.
However, for the
electronic case report form, if a patient has both an ACS and PCI within
14 days, both events can be selected.)
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 warfarin
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 < 1% when used
consistently and correctly.
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 1978
F.1.3 Elderly (>=65 years) yes
- Conditions other than atrial fibrillation that require chronic
anticoagulation (eg, prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL [133
micromol/L] or a calculated creatinine clearance < 30 mL/min
- Patients with any history of intracranial hemorrhage
- Any contraindications to warfarin, apixaban, to intended P2Y12
inhibitors or to aspirin
- Patients who have or will undergo coronary arterial bypass graft
(CABG) for their index
ACS event
- Patients with known ongoing bleeding
- Patients with known coagulopathies
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