A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy (VENTURE-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Scientific Affairs, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01729871
First received: October 23, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: December 2014
Estimated Primary Completion Date: December 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
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) 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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729871

Contacts
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

  Hide Study Locations
Locations
United States, Arizona
Withdrawn
Phoenix, Arizona, United States
United States, California
Recruiting
Beverly Hills, California, United States
Completed
Los Angeles, California, United States
Withdrawn
Newport Beach, California, United States
Recruiting
Sacramento, California, United States
Recruiting
San Francisco, California, United States
United States, Florida
Recruiting
Jacksonville, Florida, United States
Withdrawn
Lakeland, Florida, United States
United States, Georgia
Withdrawn
Atlanta, Georgia, United States
United States, Illinois
Recruiting
Maywood, Illinois, United States
Withdrawn
Oaklawn, Illinois, United States
United States, Indiana
Withdrawn
Indianapolis, Indiana, United States
United States, Kansas
Recruiting
Westwood, Kansas, United States
United States, Massachusetts
Completed
Boston, Massachusetts, United States
United States, Minnesota
Completed
St Louis Park, Minnesota, United States
United States, Missouri
Withdrawn
Kansas City, Missouri, United States
United States, New Jersey
Withdrawn
Morristown, New Jersey, United States
Completed
Ridgewood, New Jersey, United States
United States, New York
Recruiting
Flushing, New York, United States
Withdrawn
Liverpool, New York, United States
Withdrawn
New York, New York, United States
Withdrawn
Utica, New York, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
United States, Ohio
Withdrawn
Cleveland, Ohio, United States
Completed
Columbus, Ohio, United States
Withdrawn
Toledo, Ohio, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Erie, Pennsylvania, United States
Recruiting
Hershey, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
United States, Tennessee
Completed
Nashville, Tennessee, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
Dallas, Texas, United States
Withdrawn
Fort Worh, Texas, United States
Recruiting
Tyler, Texas, United States
United States, Virginia
Recruiting
Charlottesville, Virginia, United States
Withdrawn
Richmond, Virginia, United States
United States, Washington
Recruiting
Seattle, Washington, United States
Recruiting
Tacoma, Washington, United States
Belgium
Recruiting
Aalst, Belgium
Recruiting
Antwerpen, Belgium
Recruiting
Brugge, Belgium
Recruiting
Genk, Belgium
Recruiting
Hasselt, Belgium
France
Recruiting
Brest Cedex 2, France
Recruiting
Montpellier, France
Withdrawn
Paris, France
Recruiting
Pessac Cedex, France
Withdrawn
Poitiers, France
Recruiting
Toulouse Cedex 9 N/A, France
Recruiting
Vandoeuvre Les Nancy, France
Germany
Recruiting
Bad Krozingen, Germany
Recruiting
Bad Nauheim, Germany
Recruiting
Berlin, Germany
Recruiting
Dresden, Germany
Completed
Jena, Germany
Recruiting
Mönchengladbach, Germany
Recruiting
Neuwied, Germany
United Kingdom
Withdrawn
Birmingham, United Kingdom
Withdrawn
Blackpool, United Kingdom
Recruiting
Bournemouth, United Kingdom
Recruiting
Cottingham, United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
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, 2012-001484-79
Study First Received: October 23, 2012
Last Updated: August 4, 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

Keywords provided by Janssen Scientific Affairs, LLC:
Atrial Fibrillation
Irregular heart beat
Catheter Ablation
Rivaroxaban

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamin K
Vitamins
Rivaroxaban
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants

ClinicalTrials.gov processed this record on August 20, 2014