Trial Outcomes & Findings for Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion (NCT NCT01246011)
NCT ID: NCT01246011
Last Updated: 2017-11-17
Results Overview
Vein graft patency as measured by computed tomography
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
Approximately 30 Days post CABG
Results posted on
2017-11-17
Participant Flow
The study began enrolling in January 2011 and screening ended in July 2011, after it was decided that enrollment was too slow and that the study should be terminated.
Participant milestones
| Measure |
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
|
Heparin PF4 Antibody Positive no Drug
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
|
Heparin PF4 Antibody Negative
Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
|
Heparin PF4 Antibody Positive no Drug
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
|
Heparin PF4 Antibody Negative
Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
|
|---|---|---|---|
|
Overall Study
If needed warfarin clinically, withdrawn
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Baseline characteristics by cohort
| Measure |
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
|
Heparin PF4 Antibody Positive no Drug
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
|
Heparin PF4 Antibody Negative
n=9 Participants
Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
—
|
—
|
61.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately 30 Days post CABGPopulation: No analysis will be done due to early study termination
Vein graft patency as measured by computed tomography
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 2weeks post CABGPopulation: No analysis will be done due to early study termination.
Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin \> 5 g/dL.
Outcome measures
Outcome data not reported
Adverse Events
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heparin PF4 Antibody Positive no Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heparin PF4 Antibody Negative
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
|
Heparin PF4 Antibody Positive no Drug
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
|
Heparin PF4 Antibody Negative
n=8 participants at risk
Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
|
|---|---|---|---|
|
Vascular disorders
Hypotension after Coronary Artery Bypass Graft Surgery
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
25.0%
2/8 • Number of events 2 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
|
Cardiac disorders
Atrial Fibrillation after Coronary Artery Bypass Surgery
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
37.5%
3/8 • Number of events 3 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
|
Cardiac disorders
Bleeding during or immediately after Coronary Artery Bypass Surgery
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
25.0%
2/8 • Number of events 2 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
Other adverse events
| Measure |
Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
|
Heparin PF4 Antibody Positive no Drug
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
|
Heparin PF4 Antibody Negative
n=8 participants at risk
Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
|
|---|---|---|---|
|
Cardiac disorders
Low Hematocrit after Coronary Artery Bypass Graft Surgery
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
50.0%
4/8 • Number of events 4 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
|
Renal and urinary disorders
Urinary Retention after Coronary Artery Bypass Surgery
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
12.5%
1/8 • Number of events 1 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
|
Gastrointestinal disorders
Post operative nausea
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
12.5%
1/8 • Number of events 1 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
|
Musculoskeletal and connective tissue disorders
Back spasm
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
12.5%
1/8 • Number of events 1 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
|
Cardiac disorders
Pericarditis
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
12.5%
1/8 • Number of events 1 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
|
Nervous system disorders
Parkinson's-like features
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
—
0/0 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
12.5%
1/8 • Number of events 1 • 1 month
1 subject withdrew from the study prior to having a specimen drawn, so there were only 8 participants at risk
|
Additional Information
Anne Philip, Data Manager
Massachusetts General Hospital
Phone: 617 726 0423
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place