Explore the efficacy and safety of once-daily oral rivaroxaban for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1500

Inclusion Criteria

•Men or women aged = 18 years
•Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
•Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
•Written informed consent
•Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies from the time of signing of the informed consent form until 30 days after the last study drug administration. The definition of adequate contraception will be based on the judgment of the investigator and local requirements. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intrauterine device; and (iv) hormone-based contraception.

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 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

Exclusion Criteria

•Severe, disabling stroke (modified Rankin score of 4?5, inclusive; see Section 14.2) within 3 months or any stroke within 14 days before the randomization visit
•Transient ischemic attack within 3 days prior to randomization
•Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
•Acute MI within the last 14 days prior to randomization
•Cardiac-related criteria:
oKnown presence of left atrial/LAA thrombus before study inclusion
oKnown presence of atrial myxoma
oKnown left ventricular or aortic thrombus
oValvular heart disease (either hemodynamically significant mitral valve stenosis or prosthetic heart valve)
•Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
•Concomitant drugs/therapies:
oIndication for anticoagulant therapy for a condition other than atrial fibrillation (eg, VTE)
oChronic aspirin therapy > 100 mg daily or dual antiplatelet therapy
oConcomitant use of strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotic agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
•Concomitant conditions:
oChildbearing potential without proper contraceptive measures, pregnancy, or breast feeding
oHypersensitivity to investigational treatment or comparator treatment
oCalculated CrCl < 30 mL/minute (see Section 14.1)
oHepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
oAny severe condition that would limit life expectancy to less than 6 months (eg, advanced malignancy, etc.)
oPlanned invasive procedure with potential for uncontrolled bleeding, including major surgery or cardiac catheterization
oInability to take oral medication
oOngoing drug addiction or alcohol abuse
•Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
•Participation in a study with an investigational drug or medical device within 30 days prior to randomization
•Previous randomization in this study
•Inability to cooperate with the study procedures

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

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