Trial Outcomes & Findings for Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study). (NCT NCT03539055)
NCT ID: NCT03539055
Last Updated: 2025-06-10
Results Overview
Transesophageal echocardiogram or CT angiography determined presence of DRT at 90 days
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Baseline to 90 days
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
Treatment Arm
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Treatment Arm
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Screen Fail
|
7
|
|
Overall Study
Drug Intolerance
|
2
|
Baseline Characteristics
Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=100 Participants
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Age, Continuous
|
73.41 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
63 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
CHADS2 Vascular Score
|
4.3 percentage
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
HAS-BLED Score
|
3.5 percentage
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 daysPopulation: • Withdrawal from study (up to 90 days) 1. Failed to meet inclusion/exclusion criteria (n=5) 2. Withdrew consent (n=2) 3. Unable to complete and initiate 90 days or dabigatran (n=2) 4. Death prior to 90-day TEE follow-up (n=1) 5. Coud not get 90 day TEE (n=2)
Transesophageal echocardiogram or CT angiography determined presence of DRT at 90 days
Outcome measures
| Measure |
Treatment Arm
n=88 Participants
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Device Related Thrombus (DRT) at 90 Days
|
1 Participants
|
PRIMARY outcome
Timeframe: 90 days to 1 yearPopulation: • Withdrawal from study (90days to 1 year ) 1. Covid delay for 12 month TEE (n=5) 2. Patient death between 90 days and 1 year TEE (n=2\_ 3. Health decline with inability to get TEE (n=1)
Transesophageal echocardiogram or CT angiography determined presence of DRT at 1 year post implant
Outcome measures
| Measure |
Treatment Arm
n=80 Participants
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Device Related Thrombus (DRT) at 1 Year
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 90 daysPopulation: • Withdrawal from study (up to 90 days) 1. Failed to meet inclusion/exclusion criteria (n=5) 2. Withdrew consent (n=2) 3. Unable to complete and initiate 90 days or dabigatran (n=2) 4. Death prior to 90-day TEE follow-up (n=1) 5. Coud not get 90 day TEE (n=2)
Ischemic stroke, peripheral thrombo-embolic events and major bleeding events on dabigatran etexilate at 90 days
Outcome measures
| Measure |
Treatment Arm
n=88 Participants
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events
Ischemic Stroke
|
0 Participants
|
|
Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events
Peripheral thrombo-embolic events
|
0 Participants
|
|
Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events
Major Bleeds requiring intervention
|
3 Participants
|
Adverse Events
Treatment Arm
Serious events: 8 serious events
Other events: 11 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment Arm
n=88 participants at risk
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Gastrointestinal disorders
GI Bleeding
|
6.8%
6/88 • Enrollment to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.1%
1/88 • Enrollment to one year post procedure
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
1/88 • Enrollment to one year post procedure
|
Other adverse events
| Measure |
Treatment Arm
n=88 participants at risk
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
Dabigatran Etexilate Oral Capsule: Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal side effect
|
4.5%
4/88 • Enrollment to one year post procedure
|
|
Cardiac disorders
Non-ST elevation MI
|
1.1%
1/88 • Enrollment to one year post procedure
|
|
Eye disorders
Blurred Vision
|
1.1%
1/88 • Enrollment to one year post procedure
|
|
Cardiac disorders
Pericardial Pain
|
1.1%
1/88 • Enrollment to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infection
|
1.1%
1/88 • Enrollment to one year post procedure
|
|
General disorders
Headache
|
1.1%
1/88 • Enrollment to one year post procedure
|
|
Renal and urinary disorders
Hematuria
|
1.1%
1/88 • Enrollment to one year post procedure
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
1.1%
1/88 • Enrollment to one year post procedure
|
Additional Information
Terry Weyand, MS., CCRP
Vanderbilt Cardiovascular Research Enterprise
Phone: 6153229349
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place