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

Phase 1

• Conditions: prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation scheduled for cardioversion; MedDRA version: 15.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-31
• Study Completion: 2014-01-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1584

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 longer than 48 hours or of unknown duration
• Scheduled for cardioversion (electrical or pharmacological) of non-valvular 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

Subjects who meet any of the following criteria will be excluded from enrollment in the study:
• Severe disabling stroke (modified Rankin score 4-5, inclusive) within 3 months or any stroke within the last 14 days prior to randomization
• Transient ischemic attack within 3 days before 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 Pretreatment with new anticoagulant drugs, such as factor IIa or factor Xa inhibitors, within 30 days prior to randomization
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 (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 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 a investigational drug or medical device within 30 days prior to randomization
• Previous randomization in this study
• Inability to co-operate with the study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified