Clinical trial NCT01729871: A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Irregular heart beat
Catheter Ablation
Rivaroxaban
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2012-11-20
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Incidence of Post-Procedure Major Bleeding Events
timeFrame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
Secondary outcomes:
measure: Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death
timeFrame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
measure: Number of Participants With Ischemic Stroke
timeFrame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
measure: Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism
timeFrame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
measure: Number of Participants With Vascular Death
timeFrame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Maywood
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: St Louis Park
country: United States
state: Minnesota
city: Ridgewood
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Genk
country: Belgium
city: Hasselt
country: Belgium
city: Brest Cedex 2
country: France
city: Montpellier
country: France
city: Pessac Cedex
country: France
city: Toulouse Cedex 9 N/A
country: France
city: Vandoeuvre Les Nancy
country: France
city: Bad Krozingen
country: Germany
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Jena
country: Germany
city: Mönchengladbach
country: Germany
city: Neuwied
country: Germany
city: Bournemouth
country: United Kingdom
city: Cottingham
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.