Trial Outcomes & Findings for Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism (NCT NCT01976507)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

101 participants

Primary outcome timeframe

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

Results posted on

2017-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	101
Overall Study Received Initial Dose of Dabigatran	100
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 Study Adverse Event	6
Overall Study ablation not done, drug not given	1

Baseline Characteristics

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran Etexilate Mesylate n=100 Participants 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.
Age, Continuous	61 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate Mesylate n=100 Participants 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.
Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.	1 number of events

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate Mesylate n=100 Participants 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.
Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.	0 number of events

SECONDARY outcome

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

Population: This measure was removed from the protocol. No blood draws were done on any participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Dabigatran Etexilate Mesylate n=94 Participants 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.
Number of Participants With Minor Bleeding Events	3 Participants

Adverse Events

Dabigatran Etexilate Mesylate

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dabigatran Etexilate Mesylate n=100 participants at risk 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.
Blood and lymphatic system disorders Pericardial Effusion with Tamponade	1.0% 1/100 • Number of events 1

Other adverse events

Other adverse events
Measure	Dabigatran Etexilate Mesylate n=100 participants at risk 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.
Gastrointestinal disorders Upper Gi Symptoms	5.0% 5/100 • Number of events 5
Gastrointestinal disorders Tarry Stools	3.0% 3/100 • Number of events 3
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	1.0% 1/100 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	1.0% 1/100 • Number of events 1
Musculoskeletal and connective tissue disorders Fracture	1.0% 1/100 • Number of events 1
Nervous system disorders Migraine with Aura	1.0% 1/100 • Number of events 1
Cardiac disorders Pericardial Pain/Pericarditis	1.0% 1/100 • Number of events 1
Surgical and medical procedures Carotid Stenosis/Carotid Endarterectomy	1.0% 1/100 • Number of events 1

Additional Information

Christopher Ellis

Vanderbilt University Medical Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place