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

Subjects must meet the following criteria to be enrolled in the study: • Men or women aged =18 years • Hemodynamically stable non-valvular atrial fibrillation >48 hours or non-valvular atrial fibrillation of unknown duration • Scheduled for cardioversion (electrical or pharmacological) of atrial fibrillation • Provide 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 requirementsl.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Subjects who meet any of the following criteria will be excluded from enrollment in the study: • Any stroke within the last 14 days prior to randomization • Transient ischemic attack within 3 days before randomization • Acute clinical signs of systemic thromboembolic events or thrombosis 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 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 Pretreatment with new anticoagulant drugs, such as factor IIa or factor Xa inhibitors, within 30 days prior to randomization o Aspirin >100 mg or dual antiplatelet therapy o Concomitant use of strong inhibitors of both cytochrome P450 (CYP)-3A4 and P-glycoprotein (Pgp), 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 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 a investigational drug or medical device within 30 days prior to randomization • Previous randomization in this study • Inability to complete the study procedures according to protocol

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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