Phase 4
Completed N=101
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
Source: ClinicalTrials.gov NCT01976507 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Sep 2017
Primary outcomePrimary: Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation. — 1 number of events
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.