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;
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:
o Known presence of left atrial/LAA thrombus before study inclusion
o Known presence of atrial myxoma
o Known left ventricular or aortic thrombus
o Valvular 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:
o Indication for anticoagulant therapy for a condition other than atrial
fibrillation (eg, VTE)
o Chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy
o Concomitant 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:
o Childbearing potential without proper contraceptive measures,
pregnancy, or breast feeding
o Hypersensitivity to investigational treatment or comparator treatment
o Calculated CrCl < 30 mL/minute (see Section 14.1)
o Hepatic disease which is associated with coagulopathy leading to a
clinically relevant bleeding risk
o Any severe condition that would limit life expectancy to less than 6
months (eg, advanced malignancy, etc.)
o Planned invasive procedure with potential for uncontrolled bleeding,
including major surgery or cardiac catheterization
o Inability to take oral medication
o Ongoing 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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