NCT01729871

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P50-P75 for phase_3 atrial-fibrillation

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach
5 countries

44 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 10, 2015

Completed
Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

October 23, 2012

Results QC Date

October 9, 2015

Last Update Submit

January 23, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationIrregular heart beatCatheter AblationRivaroxaban

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

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

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

  • Number of Participants With Myocardial Infarction (MI)

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

  • Number of Participants With Ischemic Stroke

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

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

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

  • Number of Participants With Vascular Death

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

Study Arms (2)

rivaroxaban

EXPERIMENTAL

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

Drug: rivaroxaban

vitamin K antagonist (VKA)

EXPERIMENTAL

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)

Interventions

rivaroxabanDRUG

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

rivaroxaban
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

vitamin K antagonist (VKA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Maywood, Illinois, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Saint Louis Park, Minnesota, United States

Location

Unknown Facility

Ridgewood, New Jersey, United States

Location

Unknown Facility

Flushing, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Erie, Pennsylvania, United States

Location

Unknown Facility

Hershey, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Tyler, Texas, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Bruges, Belgium

Location

Unknown Facility

Genk, Belgium

Location

Unknown Facility

Hasselt, Belgium

Location

Unknown Facility

Brest, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Pessac, France

Location

Unknown Facility

Toulouse Cedex 9 N/A, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, France

Location

Unknown Facility

Bad Krozingen, Germany

Location

Unknown Facility

Bad Nauheim, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Jena, Germany

Location

Unknown Facility

Mönchengladbach, Germany

Location

Unknown Facility

Neuwied, Germany

Location

Unknown Facility

Bournemouth, United Kingdom

Location

Unknown Facility

Cottingham, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25975659DERIVED

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Senior Director Clinical Development
Organization
Janssen Scientific Affairs, LLC
ClinicalTrialDisclosure@its.jnj.com

Study Officials

  • Janssen Scientific Affairs, LLC Clinical Trial

    Janssen Scientific Affairs, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2012

First Posted

November 20, 2012

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 6, 2017

Results First Posted

November 10, 2015

Record last verified: 2017-01

Locations

FR(5)US(24)BE(5)DE(7)GB(3)