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Atrial FibrillationPhase 3VENTURE-AFNCT01729871

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

A Phase 3 study testing rivaroxaban and uninterrupted vitamin K antagonist (VKA) in people with Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 44 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
rivaroxaban and uninterrupted vitamin K antagonist (VKA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
44 sitesin 5 countries
Study dates
Feb 2013to Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

44 sites in 5 countries.

44 sites in 5 countries

United States24 sites

  • Study site

    Austin, Texas

  • Study site

    Beverly Hills, California

  • Study site

    Boston, Massachusetts

  • Study site

    Charlottesville, Virginia

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Durham, North Carolina

  • Study site

    Erie, Pennsylvania

  • Study site

    Flushing, New York

  • Study site

    Hershey, Pennsylvania

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Kansas

  • Study site

    Los Angeles, California

  • Study site

    Maywood, Illinois

  • Study site

    Nashville, Tennessee

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Ridgewood, New Jersey

  • Study site

    Sacramento, California

  • Study site

    Saint Louis Park, Minnesota

  • Study site

    San Francisco, California

  • Study site

    Seattle, Washington

  • Study site

    Tacoma, Washington

  • Study site

    Tyler, Texas

Other trials in United States

Germany7 sites

  • Study site

    Bad Krozingen

  • Study site

    Bad Nauheim

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Jena

  • Study site

    Mönchengladbach

  • Study site

    Neuwied

Other trials in Germany

Belgium5 sites

  • Study site

    Aalst

  • Study site

    Antwerp

  • Study site

    Bruges

  • Study site

    Genk

  • Study site

    Hasselt

Other trials in Belgium

France5 sites

  • Study site

    Brest

  • Study site

    Montpellier

  • Study site

    Pessac

  • Study site

    Toulouse Cedex 9 N/A

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

United Kingdom3 sites

  • Study site

    Bournemouth

  • Study site

    Cottingham

  • Study site

    London

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
rivaroxaban, uninterrupted vitamin K antagonist (VKA)
Keywords
Atrial Fibrillation, Irregular heart beat, Catheter Ablation, Rivaroxaban
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rivaroxabanDrug

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

  • uninterrupted vitamin K antagonist (VKA)Drug

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

Study groups in NCT01729871
Study groupRoleWhat they receive
rivaroxabanExperimentalrivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal
Receives: Drug: rivaroxaban
vitamin K antagonist (VKA)Experimentaldose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0
Receives: Drug: uninterrupted vitamin K antagonist (VKA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Incidence of Post-Procedure Major Bleeding Events

    Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.

    Measured: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

Secondary outcomes (5)

  1. Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death

    The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.

    Measured: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

  2. Number of Participants With Myocardial Infarction (MI)

    The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.

    Measured: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

  3. Number of Participants With Ischemic Stroke

    Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.

    Measured: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

  4. Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism

    The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).

    Measured: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

  5. Number of Participants With Vascular Death

    Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.

    Measured: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01729871
Sponsor's protocol ID
CR100732
Other IDs
RIVAROXAFL3002, 2012-001484-79
Acronym
VENTURE-AF
Status last verified
Jan 2017
First submitted
23 Oct 2012
Last updated
6 Mar 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 25975659

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rivaroxaban and uninterrupted vitamin K antagonist (VKA) in people with Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 44 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Germany, Belgium, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Incidence of Post-Procedure Major Bleeding Events (time frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01729871, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.

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