Trial Outcomes & Findings for Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively (NCT NCT01868243)

NCT ID: NCT01868243

Last Updated: 2015-10-09

Results Overview

The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 27 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2015-10-09

Participant Flow

Participant milestones

Measure	Dabigatran Dabigatran 110 mg BID Dabigatran: Group 1 - Dabigatran 110 mg	Warfarin Warfarin adjusted-dose Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)
Overall Study STARTED	15	12
Overall Study COMPLETED	15	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Dabigatran Dabigatran 110 mg BID Dabigatran: Group 1 - Dabigatran 110 mg	Warfarin Warfarin adjusted-dose Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)
Overall Study Death	0	1

Baseline Characteristics

Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively

Baseline characteristics by cohort

Measure	Dabigatran n=15 Participants Dabigatran 110 mg BID Dabigatran: Group 1 - Dabigatran 110 mg (50 patients)	Warfarin n=12 Participants Warfarin adjusted-dose Warfarin: Warfarin adjusted-dose	Total n=27 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 10 • n=5 Participants	46 years STANDARD_DEVIATION 6 • n=7 Participants	47 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Brazil	15 participants n=5 Participants	12 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: A total of 34 patients were selected between August 2013 and November 2014 (6 were excluded for previous intracardiac thrombus; 1 for unstable INR control). Of the 27 randomized, 15 were assigned to receive dabigatran and 12 to receive warfarin.

The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).

Outcome measures

Measure	Dabigatran n=15 Participants Dabigatran 110 mg BID Dabigatran: Group 1 - Dabigatran 110 mg	Warfarin n=12 Participants Warfarin adjusted-dose Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)
Intracardiac Thrombus	0 participants Interval 0.0 to 0.0	1 participants Interval 0.9 to 1.3

SECONDARY outcome

Timeframe: 90 days

Spontaneous Echo Contrast showed in Transesophageal echocardiography

Outcome measures

Measure	Dabigatran n=15 Participants Dabigatran 110 mg BID Dabigatran: Group 1 - Dabigatran 110 mg	Warfarin n=12 Participants Warfarin adjusted-dose Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)
Spontaneous Echo Contrast	2 participants	1 participants

Adverse Events

Dabigatran

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Warfarin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dabigatran n=15 participants at risk Dabigatran 110 mg BID Dabigatran: Group 1 - Dabigatran 110 mg	Warfarin n=12 participants at risk Warfarin adjusted-dose Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)
Nervous system disorders Stroke	6.7% 1/15 • Number of events 1	0.00% 0/12

Other adverse events

Measure	Dabigatran n=15 participants at risk Dabigatran 110 mg BID Dabigatran: Group 1 - Dabigatran 110 mg	Warfarin n=12 participants at risk Warfarin adjusted-dose Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)
Gastrointestinal disorders Bleeding	6.7% 1/15 • Number of events 1	8.3% 1/12 • Number of events 1

Additional Information

Andre Rodrigues Duraes

Hospital Ana Nery

Phone: +557191888399

Email: andreduraes@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place