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

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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
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