Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 333 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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atrial Fibrillation
Atrial Flutter
Intervention Drug: dabigatran etexilate mesylate
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate Mesylate
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 101
Received Initial Dose of Dabigatran 100
Completed 94
Not Completed 7
Reason Not Completed
Adverse Event             6
ablation not done, drug not given             1
Arm/Group Title Dabigatran Etexilate Mesylate
Hide Arm/Group Description

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.

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.

Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
61  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
28
  28.0%
Male
72
  72.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants
100
1.Primary Outcome
Title Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.
Hide Description [Not Specified]
Time Frame Within 4 months following procedure (+/- 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dabigatran Etexilate Mesylate
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: number of events
1
2.Primary Outcome
Title Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.
Hide Description [Not Specified]
Time Frame Within 4 months following procedure (+/- 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dabigatran Etexilate Mesylate
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: number of events
0
3.Secondary Outcome
Title Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event.
Hide Description [Not Specified]
Time Frame Within 4 months following procedure (+/- 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was removed from the protocol. No blood draws were done on any participants.
Arm/Group Title Dabigatran Etexilate Mesylate
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Minor Bleeding Events
Hide Description [Not Specified]
Time Frame Within 4 months following procedure (+/- 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dabigatran Etexilate Mesylate
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 94
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate Mesylate
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Dabigatran Etexilate Mesylate
Affected / at Risk (%)
Total   0/100 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate Mesylate
Affected / at Risk (%) # Events
Total   1/100 (1.00%)    
Blood and lymphatic system disorders   
Pericardial Effusion with Tamponade   1/100 (1.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dabigatran Etexilate Mesylate
Affected / at Risk (%) # Events
Total   14/100 (14.00%)    
Cardiac disorders   
Pericardial Pain/Pericarditis   1/100 (1.00%)  1
Gastrointestinal disorders   
Upper Gi Symptoms   5/100 (5.00%)  5
Tarry Stools   3/100 (3.00%)  3
Musculoskeletal and connective tissue disorders   
Fracture *  1/100 (1.00%)  1
Nervous system disorders   
Migraine with Aura   1/100 (1.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pleuritic Pain   1/100 (1.00%)  1
Pneumonia   1/100 (1.00%)  1
Surgical and medical procedures   
Carotid Stenosis/Carotid Endarterectomy   1/100 (1.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Ellis
Organization: Vanderbilt University Medical Center
EMail: christopher.ellis@Vanderbilt.Edu
Layout table for additonal information
Responsible Party: Christopher Ellis, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01976507     History of Changes
Other Study ID Numbers: 121204
First Submitted: October 29, 2013
First Posted: November 5, 2013
Results First Submitted: August 13, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017