- Subjects with non-valvular atrial fibrillation (as documented by electrocardiogram
(ECG) at Visit 1) indicated for cardioversion and initiation of anticoagulation in
accordance with the approved local label. Subjects presenting with atrial flutter with
no evidence of atrial fibrillation are not eligible for enrolment.
- Age ≥18 years (Age ≥ 19 years for Korea only and Age ≥ 20 years for Japan only).
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or their legally-recognized representative) has been informed of all
pertinent aspects of the study.
- The subject is willing to provide contact details for at least one alternate person
for study staff to contact regarding their whereabouts, should the subject be
lost-to-follow-up over the course of the study. (Subject to IRB/IEC approval)
- Female subjects of childbearing potential must agree to use a highly effective method
of contraception throughout the study and for at least 28 days after the last dose of
assigned treatment. A subject is of childbearing potential if, in the opinion of the
investigator, she is biologically capable of having children and is sexually active.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, and
other study procedures.
- Subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral)
immediately prior to randomization.
- Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved
- Severe haemodynamically compromised subjects requiring emergent cardioversion.
- Patients with hemodynamically significant mitral stenosis, mechanical or biological
prosthetic valve or valve repair.
- Conditions other than atrial fibrillation that require chronic anticoagulation (eg, a
prosthetic heart valve).
- Simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel,
ticlopidine, prasugrel) or simultaneous treatment with both aspirin and ticagrelor.
- Pregnant females; breastfeeding females; females of childbearing potential who are
unwilling or unable to use a highly effective method of contraception as outlined in
this protocol for the duration of the study and for at least 28 days after last dose
of investigational product.
- Participation in other studies involving investigational drug(s) (Phases 1-4) within
30 days before the current study begins and/or during study participation. Note:
Subjects cannot be randomized into this study more than once.
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and,
in the judgment of the investigator, would make the subject inappropriate for entry
into this study.
- Subjects who are investigational site staff members directly involved in the conduct
of the trial and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are BMS/Pfizer employees directly involved in the
conduct of the trial.