A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy (VENTURE-AF)
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Purpose
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.
| 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 ]
| Enrollment: | 253 |
| Study Start Date: | February 2013 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | October 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 (both physicians and participants know the identity of the assigned treatment), active-controlled, multi-center safety 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 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. Approximately 250 eligible participants, age 18 years or older, with a history of paroxysmal, persistent, or long standing persistent NVAF who are scheduled to undergo an elective catheter ablation procedure will be randomized in a 1:1 ratio to receive either rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal or VKA (adjusted to achieve a recommended International Normalized Ratio of 2.0 to 3.0).
The study will consist of a screening period, a pre-procedure period, procedure period and post-procedure period. The screening period will begin up to 2 weeks prior to randomization. Participants will be randomized at the beginning of the pre-procedure period. During this period, participants will be recommended to receive their assigned treatment for at least 4 weeks (maximum of 5 weeks) before the catheter ablation procedure. For participants with the sufficient anticoagulation, documented for the 3 weeks prior to randomization, and for participants with a transesophageal echocardiogram (TEE) or intracardiac echocardiography (ICE), the length of the pre-procedure period may be reduced down to 1-7 days and must include any transition from the previous anticoagulation therapy to randomized study drug.
After the catheter ablation procedure, participants will receive their post-procedure dose of study drug through a minimum of 30 + - 5 days. In addition to scheduled visits and telephone calls the study 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 a 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), or long standing persistent (>=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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01729871
Show 44 Study Locations
| Study Director: | Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC |
More Information
No publications provided
| Responsible Party: | Janssen Scientific Affairs, LLC |
| ClinicalTrials.gov Identifier: | NCT01729871 History of Changes |
| Other Study ID Numbers: | CR100732, RIVAROXAFL3002, 2012-001484-79 |
| Study First Received: | October 23, 2012 |
| Last Updated: | November 5, 2014 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Germany: Ethics Commission Great Britain: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Janssen Scientific Affairs, LLC:
|
Atrial Fibrillation Irregular heart beat Catheter Ablation Rivaroxaban |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Rivaroxaban Vitamin K Anticoagulants Antifibrinolytic Agents Coagulants |
Fibrin Modulating Agents Growth Substances Hematologic Agents Hemostatics Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vitamins |
ClinicalTrials.gov processed this record on March 03, 2015