Phase 3
N=1,504
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
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01674647 ↗Enrolled (actual)
1,504
Serious AEs
8.8%
Results posted
Feb 2015
Primary outcome: Primary: Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death — 5; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939) (Drug); Vitamin K antagonist (VKA) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death |
5; 5 | — |
| PRIMARY Number of Participants With Major Bleedings as Per Central Adjudication |
6; 4 | — |
| SECONDARY Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms |
2; 3 | — |
| SECONDARY Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality |
6; 6 | — |
| SECONDARY Number of Participants With Strokes |
2; 2 | — |
| SECONDARY Number of Participants With Transient Ischemic Attacks |
0; 0 | — |
| SECONDARY Number of Participants With Non-central Nervous System Systemic Embolisms |
0; 1 | — |
| SECONDARY Number of Participants With Myocardial Infarctions |
1; 1 | — |
| SECONDARY Number of Participants With Cardiovascular Deaths |
4; 2 | — |
| SECONDARY Number of Participants With All-cause Mortality |
5; 3 | — |
| SECONDARY Number of Participants With Composite of Major and Non-major Bleeding Events |
33; 14 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01674647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.