Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vanderbilt University
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Christopher Ellis, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01976507
First received: October 29, 2013
Last updated: June 26, 2014
Last verified: June 2014

October 29, 2013
June 26, 2014
October 2013
October 2015   (final data collection date for primary outcome measure)
Frequency of major bleeding complications and thrombo-embolic events in patients administered dabigatran following RF ablation. [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
Determine frequency of major bleeding complications and thrombo-embolic events in patients administered dabigatran following RF ablation. [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01976507 on ClinicalTrials.gov Archive Site
  • Dabigatran serum drug levels in patients experiencing a major bleeding or thrombo-embolic event. [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
  • Frequency of minor bleeding events [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
  • Determine dabigatran serum drug levels in patients experiencing a major bleeding or thrombo-embolic event. [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
  • Determine frequency of minor bleeding events [ Time Frame: Within 4 months following procedure (+/- 4 days) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism in Patients Undergoing Left Atrial Catheter Ablation Procedures for Paroxysmal or Persistent (Non-permanent) Atrial Fibrillation and Left Atrial Flutter

The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency ablation, or cryoablation procedures.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Atrial Fibrillation
  • Atrial Flutter
Drug: dabigatran etexilate mesylate
Other Name: Pradaxa
Experimental: dabigatran etexilate mesylate
Intervention: Drug: dabigatran etexilate mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2016
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female sex, age 18-85 years.
  • Negative pregnancy test for women of childbearing potential
  • Planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (NVAF), or left atrial flutter following prior left atrial ablation procedures
  • CHADS2 score of 0-6 or CHADS2-VASc score 0-9
  • Vascular hemostasis within 4-6 hours of sheath pull
  • Able to give informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Currently participating in another clinical treatment trial
  • History of hereditary hemophilias
  • Presence of active bleeding
  • End stage renal disease, CrCl<15 mL/min
  • Prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
  • Known allergic reaction to dabigatran etexilate
  • Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI.
  • Pregnancy
  • History of non-compliance
  • Inability to follow-up
Both
18 Years to 85 Years
No
Contact: Sherry Bowman, RN 615-875-5500
United States
 
NCT01976507
121204
No
Christopher Ellis, Vanderbilt University
Vanderbilt University
Boehringer Ingelheim
Principal Investigator: Christopher R Ellis, MD Vanderbilt University
Vanderbilt University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP