Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/23/2013 |
Start Date: | October 2012 |
End Date: | January 2014 |
Contact: | Bayer Clinical Trials Contact |
Email: | clinical-trials-contact@bayerhealthcare.com |
A Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral Vitamin K Antagonists (VKA) for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo
cardioversion (procedure to restore normal heart rhythm). The study will compare patients
assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist
(VKA). The study will measure common medical outcomes for this type of patient such as
bleeding and stroke.
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
- Women of childbearing potential and men must agree to use adequate contraception when
sexually active
Exclusion Criteria:
- Severe, disabling stroke (modified Rankin score of 4- 5, inclusive) within 3 months
or any stroke within 14 days prior to randomization
- 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 Myocardial infarction (MI) within the last 14 days prior to randomization
- Cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular
atrial fibrillation
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
- Concomitant medications: indication for anticoagulant therapy other than atrial
fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy,
strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) if used
systemically
- Concomitant conditions: childbearing potential without proper contraceptive measures,
pregnancy, or breast feeding; hypersensitivity to investigational treatment or
comparator treatment; calculated creatinine clearance (CrCl) < 30 mL/minute; hepatic
disease which is associated with coagulopathy leading to a clinically relevant
bleeding risk; any severe condition that would limit life expectancy to less than 6
months; planned invasive procedure with potential for uncontrolled bleeding;
inability to take oral medication; 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
We found this trial at
23
sites
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