Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

NCT01976507 | Completed Phase 4 Results

• 1 other identifier: 121204
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (2)

• Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.

  Within 4 months following procedure (+/- 4 days)

• Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.

  Within 4 months following procedure (+/- 4 days)

Secondary Outcomes (2)

• Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event.

  Within 4 months following procedure (+/- 4 days)

• Number of Participants With Minor Bleeding Events

  Within 4 months following procedure (+/- 4 days)

Study Arms (1)

dabigatran etexilate mesylate

EXPERIMENTAL

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.

Drug: dabigatran etexilate mesylate

Interventions

dabigatran etexilate mesylate DRUG

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.

Also known as: Pradaxa

dabigatran etexilate mesylate

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Christopher Ellis
• Organization: Vanderbilt University Medical Center

christopher.ellis@Vanderbilt.Edu

Study Officials

• Christopher R Ellis, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 12, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-08

Locations

US (1)