The purpose of this study is to assess the good and bad effects (efficacy and safety) of apixaban compared with usual care anticoagulation in people with Atrial Fibrillation in whom an early cardioversion is planned.
- Conditions
- on-Valvular Atrial Fibrillation in patients undergoing CardioversionMedDRA version: 19.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-001231-36-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
1.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 enrollment.
2.Age =18 years (Age =19 years for Korea only and Age =20 years for
Japan only).
3.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.
4.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.
5.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.
6.Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1050
1. Subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral) immediately prior to randomization.
2. Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved local label.
3. Severe haemodynamically compromised subjects requiring emergent cardioversion.
4. Patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair.
5. Conditions other than atrial fibrillation that require chronic
anticoagulation (eg, a prosthetic heart valve).
6. Simultaneous treatment with both aspirin and a thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel or simultaneous treatment with both aspirin and ticagrelor)
7. 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.
8. 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.
9. 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.
10. 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.
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