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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Janssen Research & Development, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
