A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy (VENTURE-AF)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult subjects with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events. The secondary objective of this study is to evaluate the thromboembolism profile of rivaroxaban and uninterrupted VKA as measured by the composite and the individual components of the following post procedure events: myocardial infarction (MI), ischemic stroke, non-central nervous system (CNS) systemic embolism, and vascular death.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: rivaroxaban Drug: uninterrupted vitamin K antagonist (VKA) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation |
- Incidence of post-procedure major bleeding events [ Time Frame: During the first 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
- Event rate of the composite endpoint of myocardial infarction (MI), ischemic stroke, non-Central Nervous System (non-CNS) systemic embolism and vascular death [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
- Event rate of myocardial infarction (MI) [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
- Event rate of ischemic stroke [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
- Event rate of non-Central Nervous System (non-CNS) systemic embolism [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
- Event rate of vascular death [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: rivaroxaban
rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal
|
Drug: rivaroxaban
rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal
|
|
Experimental: vitamin K antagonist (VKA)
dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0
|
Drug: uninterrupted vitamin K antagonist (VKA)
dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0
|
Detailed Description:
This is a randomized (participants are assigned to intervention groups by chance), open-label (all involved people know the identity of the intervention), active-controlled, multi-center clinical study of rivaroxaban or VKA before and after a catheter ablation procedure. This study requires collaboration with medical institutions that provide access to electrophysiologists who normally perform the catheter ablation procedure. In order to achieve 200 per-protocol participants, approximately 250 eligible participants, age 18 years or older, with a history of paroxysmal or persistent NVAF who are scheduled to undergo their first elective catheter ablation procedure will be randomized in a 1:1 ratio to receive either rivaroxaban 20 mg orally, once daily, preferably administered with the evening meal or uninterrupted VKA (adjusted to achieve a recommended INR of 2.0 to 3.0). In this study, NVAF is to be defined as the presence of AF in a person who does not have a prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted) and who does not have hemodynamically significant mitral valve stenosis. The screening period will begin up to 2 weeks prior to randomization. The study will include scheduled visits and telephone calls and may also include additional phone calls and visits by the participant to the site when dose adjustment is required for usual care.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be scheduled for first catheter ablation procedure for non-valvular atrial fibrillation (NVAF); - Have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion in <1 week) 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 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 long standing persistence of NVAF, or is scheduled for a repeat catheter ablation procedure within 3 months of the initial catheter ablation procedure; - 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.
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Show 31 Study Locations| Study Director: | Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Scientific Affairs, LLC |
| ClinicalTrials.gov Identifier: | NCT01729871 History of Changes |
| Other Study ID Numbers: | CR100732, RIVAROXAFL3002 |
| Study First Received: | October 23, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Germany: Ethics Commission Great Britain: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Janssen Scientific Affairs, LLC:
|
Atrial Fibrillation Irregular heart beat Catheter Ablation |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Diseases Atrial Fibrillation Cardiovascular Diseases Pathologic Processes Vitamin K Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013