A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy

NCT ID: NCT01729871

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-10-31

Brief 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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rivaroxaban

rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal

vitamin K antagonist (VKA)

dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0

Group Type: EXPERIMENTAL

uninterrupted vitamin K antagonist (VKA)

Intervention Type: DRUG

dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0

Interventions

rivaroxaban

rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal

Intervention Type: 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

Intervention Type: DRUG

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) 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

Beverly Hills, California, United States

Los Angeles, California, United States

Sacramento, California, United States

San Francisco, California, United States

Jacksonville, Florida, United States

Maywood, Illinois, United States

Kansas City, Kansas, United States

Boston, Massachusetts, United States

Saint Louis Park, Minnesota, United States

Ridgewood, New Jersey, United States

Flushing, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Portland, Oregon, United States

Erie, Pennsylvania, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Tyler, Texas, United States

Charlottesville, Virginia, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Aalst, , Belgium

Antwerp, , Belgium

Bruges, , Belgium

Genk, , Belgium

Hasselt, , Belgium

Brest, , France

Montpellier, , France

Pessac, , France

Toulouse Cedex 9 N/A, , France

Vandœuvre-lès-Nancy, , France

Bad Krozingen, , Germany

Bad Nauheim, , Germany

Berlin, , Germany

Dresden, , Germany

Jena, , Germany

Mönchengladbach, , Germany

Neuwied, , Germany

Bournemouth, , United Kingdom

Cottingham, , United Kingdom

London, , United Kingdom

Countries

United States; Belgium; France; Germany; United Kingdom

References

Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G, Vijgen J, Hugl BJ, Balasubramaniam R, De Chillou C, Davies DW, Fields LE, Natale A; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.

Reference Type: DERIVED

PMID: 25975659 (View on PubMed)

Other Identifiers

RIVAROXAFL3002

Identifier Type: OTHER

Identifier Source: secondary_id

2012-001484-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100732

Identifier Type: -

Identifier Source: org_study_id