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Trial record 5 of 339 for:    DABIGATRAN

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01976507
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Christopher Ellis, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE October 29, 2013
First Posted Date  ICMJE November 5, 2013
Results First Submitted Date  ICMJE August 13, 2017
Results First Posted Date  ICMJE September 12, 2017
Last Update Posted Date September 12, 2017
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2017)
  • Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation. [ Time Frame: Within 4 months following procedure (+/- 4 days) ]
  • Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation. [ Time Frame: Within 4 months following procedure (+/- 4 days) ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2013)
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) ]
Change History Complete list of historical versions of study NCT01976507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2017)
  • Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event. [ Time Frame: Within 4 months following procedure (+/- 4 days) ]
  • Number of Participants With Minor Bleeding Events [ Time Frame: Within 4 months following procedure (+/- 4 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2013)
  • Determine dabigatran serum drug levels in patients experiencing a major bleeding or thrombo-embolic event. [ Time Frame: Within 4 months following procedure (+/- 4 days) ]
  • Determine frequency of minor bleeding events [ Time Frame: Within 4 months following procedure (+/- 4 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

Study design

Approximately 100 patients who plan to have pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, or left atrial flutter following prior left atrial ablation procedures, with CHADS2 score of 0-6 or CHADS2-VASc score 0-9 will be eligible for this trial and enrolled. A transesophageal echocardiogram (TEE) will be performed pre-procedure based on the presenting cardiac rhythm the day of planned catheter ablation, stroke risk by CHADS2 or CHADS2-VASc score, and preceding use of therapeutic anti-coagulation (as per current 2012 HRS/ACC/ESC guidelines on atrial fibrillation management). Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation. This represents the standard blanking period for post atrial fibrillation or left atrial flutter catheter ablation anticoagulation therapy. After the 3 months blanking period, patients may safely be taken off dabigatran in the low risk group for stroke or thromboembolism, according to the investigators discretion (CHADS 2 score 0-1, or CHADS2-VASc score 0-1). If on dabigatran etexilate pre-procedure, the drug will be held at least 24 hours before the intervention depending on renal function of the patient (as per recommendations in the USPI). If possible, discontinue dabigatran 1 to 2 days (CrCl >50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before an invasive or surgical procedure, due to increased risk of bleeding.

Dabigatran etexilate will be resumed 4-6 hours after sheath pull and vascular hemostasis post ablation as above. Intra-procedure intravenous heparin drip will be started once left atrial access is obtained with an ACT goal target 300-350 seconds by weight based nomogram. Standardized ablation endpoints (4 vein entrance and exit block with post ablation adenosine challenge and/or isoproterenol, or termination of left atrial flutter and completion of linear ablation confirmed by differential pacing) will be documented, along with radiofrequency or cryoablation

delivery time, fluoroscopy and total case time. Inpatient adverse events will be documented, and outpatient follow up will occur at 1 and 3 months post ablation per standard protocol, with documentation of all composite endpoints (see below). In addition, a 30 day post study phone call follow up will be performed (30 days +/- 4 days following the 3 month visit). Please see Table 1 for the schedule of events.

Our hypothesis is that exposure to dabigatran in the setting of AF left atrial catheter ablation will be associated with alow or acceptable risk of major adverse bleeding risks, and low thromboembolic event rates post RF ablation, in accordance with our previous data, and in contrary to the findings of Lakireddy, et al, in their retrospective study published 2012 in JACC. This could lead to widespread utilization of dabigatran etexilate for centers performing a high number of atrial fibrillation and left atrial flutter ablation procedures.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Flutter
Intervention  ICMJE Drug: dabigatran etexilate mesylate
Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.
Other Name: Pradaxa
Study Arms  ICMJE Experimental: dabigatran etexilate mesylate
Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.
Intervention: Drug: dabigatran etexilate mesylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2015)
101
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2013)
100
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01976507
Other Study ID Numbers  ICMJE 121204
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Christopher Ellis, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Boehringer Ingelheim
Investigators  ICMJE
Principal Investigator: Christopher R Ellis, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date August 2017

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