Trial Outcomes & Findings for DOT HeartMate 3 Study (NCT NCT04974684)
NCT ID: NCT04974684
Last Updated: 2024-08-20
Results Overview
Evaluation survival free of major hemocompatibility related adverse events (HRAEs). Major HRAEs include: * Stroke (ischemic/hemorrhagic) * Pump thrombosis * Severe bleeding (see Appendix II) * Peripheral arterial thromboembolic events Comparison of HRAEs in apixaban and control group per protocol. Separate analysis in patients randomized to receive aspirin and no-aspirin within the apixaban group as specified in protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
6 months
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Apixaban Alone Group
This study group contained 16 patients that were given only apixaban 5mg twice a day.
|
Apixaban + Aspirin Group
This group contained 15 patients that were given apixaban 5 mg twice a day + aspirin 100mg a day.
|
Warfarin + Aspirin Group
This study group contained 14 patients that were treated following standard anticoagulation protocol (Warfarin INR 2-3 + aspirin 100mg/day).
|
|---|---|---|---|
|
3 Months
STARTED
|
16
|
15
|
14
|
|
3 Months
COMPLETED
|
15
|
13
|
13
|
|
3 Months
NOT COMPLETED
|
1
|
2
|
1
|
|
6 Months
STARTED
|
15
|
13
|
13
|
|
6 Months
COMPLETED
|
13
|
9
|
12
|
|
6 Months
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DOT HeartMate 3 Study
Baseline characteristics by cohort
| Measure |
Apixaban Alone Group
n=16 Participants
This study group contained 16 patients that were given only apixaban 5mg twice a day.
|
Apixaban + Aspirin Group
n=15 Participants
This study group contained 15 patients that were given apixaban 5mg twice a day + aspirin 100mg a day.
|
Warfarin + Aspirin Group
n=14 Participants
This study group contained 14 patients that were treated following standard anticoagulation protocol (Warfarin INR 2-3 + aspirin 100mg/day).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
23 Participants
n=157 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
59.7 years
STANDARD_DEVIATION 16.3 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
61.7 years
STANDARD_DEVIATION 12.6 • n=157 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
40 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
45 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
Czechia
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
45 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 6 monthsEvaluation survival free of major hemocompatibility related adverse events (HRAEs). Major HRAEs include: * Stroke (ischemic/hemorrhagic) * Pump thrombosis * Severe bleeding (see Appendix II) * Peripheral arterial thromboembolic events Comparison of HRAEs in apixaban and control group per protocol. Separate analysis in patients randomized to receive aspirin and no-aspirin within the apixaban group as specified in protocol.
Outcome measures
| Measure |
Apixaban Alone Group
n=16 Participants
This study group included 16 patients that were given apixaban 5mg twice a day.
|
Apixaban + Aspirin Group
n=15 Participants
This study group included 15 patients that were given apixaban 5 mg twice a day and aspirin 100mg per day.
|
Warfarin + Aspirin Group
n=14 Participants
This study group contained 14 patients treated following standard anticoagulation protocol (Warfarin INR 2-3 + aspirin 100mg/day).
|
|---|---|---|---|
|
Evaluation of Hemocompatibility Related Adverse Events During Apixaban Use With the HeartMate 3 LVAS
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 year.The events evaluated are as follows: * Stroke (ischemic/hemorrhagic) * Pump thrombosis * Major bleeding * GI Bleeding * Peripheral arterial thromboembolic events * Transient ischemic attack * Hemolysis * Venous thromboembolism * Myocardial infarction * Right heart failure * Cardiac arrhythmias * Liver and kidney dysfunction * Death due to any cause
Outcome measures
Outcome data not reported
Adverse Events
Apixaban Alone Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Apixaban + Aspirin Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Warfarin + Aspirin Group
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apixaban Alone Group
n=16 participants at risk
This study group contained 16 patients that were given apixaban 5mg twice a day.
|
Apixaban + Aspirin Group
n=15 participants at risk
This study group contained 15 patients that were given apixaban 5mg twice a day and aspirin 100mg per day.
|
Warfarin + Aspirin Group
n=14 participants at risk
This study group contained 14 patients that were treated following standard anticoagulation protocol (Warfarin INR 2-3 + aspirin 100mg/day).
|
|---|---|---|---|
|
Gastrointestinal disorders
GI bleeding
|
0.00%
0/16 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/14 • 6 months
|
|
Infections and infestations
Driveline infection
|
0.00%
0/16 • 6 months
|
20.0%
3/15 • Number of events 3 • 6 months
|
21.4%
3/14 • Number of events 3 • 6 months
|
|
Infections and infestations
Mediastinitis
|
6.2%
1/16 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
7.1%
1/14 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypovolemia
|
6.2%
1/16 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
14.3%
2/14 • Number of events 2 • 6 months
|
|
Cardiac disorders
Right heart failure
|
6.2%
1/16 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
0.00%
0/14 • 6 months
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/16 • 6 months
|
0.00%
0/15 • 6 months
|
7.1%
1/14 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Hip luxation
|
6.2%
1/16 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
0.00%
0/14 • 6 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/16 • 6 months
|
0.00%
0/15 • 6 months
|
7.1%
1/14 • Number of events 1 • 6 months
|
|
Infections and infestations
Positive blood cultures
|
0.00%
0/16 • 6 months
|
0.00%
0/15 • 6 months
|
7.1%
1/14 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • 6 months
|
0.00%
0/15 • 6 months
|
7.1%
1/14 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place