Phase 3
N=248
A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01729871 ↗Enrolled (actual)
248
Serious AEs
15.2%
Results posted
Nov 2015
Primary outcome: Primary: Number of Participants With Incidence of Post-Procedure Major Bleeding Events — 0; 0; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rivaroxaban (Drug); uninterrupted vitamin K antagonist (VKA) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Scientific Affairs, LLC
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incidence of Post-Procedure Major Bleeding Events |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death |
0; 2 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) |
0; 0 | — |
| SECONDARY Number of Participants With Ischemic Stroke |
0; 1 | — |
| SECONDARY Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism |
0; 0 | — |
| SECONDARY Number of Participants With Vascular Death |
0; 1 | — |
Summary
The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.
Eligibility Criteria
Inclusion Criteria
- Be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation (NVAF);
- Have a documented history of paroxysmal (lasting 1 week and =1 year) NVAF;
- Be suitable for anticoagulant therapy and catheter ablation as per the judgment of the investigator;
- Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active;
- Women of childbearing potential must have a negative serum pregnancy test at screening;
- Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol;
- Have a life expectancy of at least 6 months
Exclusion Criteria
- Has a history of a prior stroke, transient ischemic attack (TIA) or non-convulsive status epilepticus within 6 months of the screening visit;
- Has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure;
- Has had major surgery (requiring general anesthesia), within 6 months before screening or planned surgery during the time the subject is expected to participate in the study;
- Has NVAF due to electrolyte imbalance, hyperthyroidism, or other reversible or noncardiac cause of NVAF;
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Data sourced from ClinicalTrials.gov (NCT01729871). 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.