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

• Conditions: prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation scheduled for cardioversion; MedDRA version: 14.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002234-39-FI
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-13
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 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 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 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