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

Information source: Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: rivaroxaban (Drug); uninterrupted vitamin K antagonist (VKA) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Janssen Scientific Affairs, LLC

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of post-procedure major bleeding events

Secondary outcome:

Event rate of the composite endpoint of myocardial infarction (MI), ischemic stroke, non-Central Nervous System (non-CNS) systemic embolism and vascular death

Event rate of myocardial infarction (MI)

Event rate of ischemic stroke

Event rate of non-Central Nervous System (non-CNS) systemic embolism

Event rate of vascular death

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Aalst, Belgium

Antwerpen, Belgium

Brugge, Belgium

Genk, Belgium

Hasselt, Belgium

Brest Cedex 2, France

Montpellier, France

Pessac Cedex, France

Toulouse Cedex 9 N/A, France

Vandoeuvre Les 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

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

Westwood, Kansas, United States

Boston, Massachusetts, United States

St 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

Additional Information

Starting date: February 2013
Last updated: November 5, 2014

Page last updated: August 23, 2015

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