Phase 4 N=101 Treatment

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

Atrial Fibrillation · Atrial Flutter

Bottom Line

View on ClinicalTrials.gov: NCT01976507 ↗

Enrolled (actual)

101

Serious AEs

1.0%

Results posted

Sep 2017

Primary outcome: Primary: Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation. — 1 number of events

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: dabigatran etexilate mesylate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.	1	—
PRIMARY Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.	—	—
SECONDARY Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event.	—	—
SECONDARY Number of Participants With Minor Bleeding Events	3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01976507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.