Trial Outcomes & Findings for Antiplatelet Therapy in HIV (NCT NCT02559414)
NCT ID: NCT02559414
Last Updated: 2018-10-15
Results Overview
The primary objective of these analyses will be to compare the effects of aspirin versus control and clopidogrel versus control for the outcome of platelet activity. Aspirin is expected to decrease arachidonic acid-induced platelet aggregation by 50% versus control. Clopidogrel is expected to decrease ADP-induced platelet aggregation by 50% versus control.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Baseline, 14 Days
Results posted on
2018-10-15
Participant Flow
Participant milestones
| Measure |
Control
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Aspirin
This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.
Aspirin
|
Clopidogrel
This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.
Clopidogrel
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
22
|
22
|
|
Overall Study
COMPLETED
|
10
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Control
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Aspirin
This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.
Aspirin
|
Clopidogrel
This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.
Clopidogrel
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
1
|
Baseline Characteristics
Antiplatelet Therapy in HIV
Baseline characteristics by cohort
| Measure |
Control
n=11 Participants
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Aspirin
n=22 Participants
This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.
Aspirin
|
Clopidogrel
n=22 Participants
This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.
Clopidogrel
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 14 DaysThe primary objective of these analyses will be to compare the effects of aspirin versus control and clopidogrel versus control for the outcome of platelet activity. Aspirin is expected to decrease arachidonic acid-induced platelet aggregation by 50% versus control. Clopidogrel is expected to decrease ADP-induced platelet aggregation by 50% versus control.
Outcome measures
| Measure |
Placebo Baseline
n=10 Participants
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Placebo Follow up
n=9 Participants
|
Aspirin Baseline
n=14 Participants
|
Aspirin Randomization
n=13 Participants
|
Clopidogrel Baseline
n=21 Participants
|
Clopidogrel Randomization
n=16 Participants
|
|---|---|---|---|---|---|---|
|
Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min
|
72.35 %aggregation
Standard Error 5.71
|
79.11 %aggregation
Standard Error 3.15
|
72.79 %aggregation
Standard Error 5.11
|
26.77 %aggregation
Standard Error 7.61
|
71.07 %aggregation
Standard Error 6.16
|
65.00 %aggregation
Standard Error 8.16
|
SECONDARY outcome
Timeframe: Baseline, 14 DaysOutcome measures
| Measure |
Placebo Baseline
n=10 Participants
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Placebo Follow up
n=9 Participants
|
Aspirin Baseline
n=14 Participants
|
Aspirin Randomization
n=13 Participants
|
Clopidogrel Baseline
n=21 Participants
|
Clopidogrel Randomization
n=16 Participants
|
|---|---|---|---|---|---|---|
|
Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min
|
69.45 %aggregation
Standard Error 9.04
|
80.33 %aggregation
Standard Error 2.77
|
82.04 %aggregation
Standard Error 2.44
|
62.00 %aggregation
Standard Error 5.50
|
78.86 %aggregation
Standard Error 3.45
|
39.88 %aggregation
Standard Error 7.95
|
SECONDARY outcome
Timeframe: 14 DaysSecondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation
Outcome measures
| Measure |
Placebo Baseline
n=10 Participants
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Placebo Follow up
n=9 Participants
|
Aspirin Baseline
n=14 Participants
|
Aspirin Randomization
n=13 Participants
|
Clopidogrel Baseline
n=21 Participants
|
Clopidogrel Randomization
n=16 Participants
|
|---|---|---|---|---|---|---|
|
Percentage Monocyte-Platelet Aggregates
|
69.45 %aggregation
Standard Error 9.04
|
80.33 %aggregation
Standard Error 2.77
|
82.04 %aggregation
Standard Error 2.44
|
62.00 %aggregation
Standard Error 5.50
|
78.86 %aggregation
Standard Error 3.45
|
39.88 %aggregation
Standard Error 7.95
|
SECONDARY outcome
Timeframe: 14 DaysSecondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity
Outcome measures
| Measure |
Placebo Baseline
n=8 Participants
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Placebo Follow up
n=7 Participants
|
Aspirin Baseline
n=10 Participants
|
Aspirin Randomization
n=8 Participants
|
Clopidogrel Baseline
n=16 Participants
|
Clopidogrel Randomization
n=13 Participants
|
|---|---|---|---|---|---|---|
|
Percentage Monocyte-Platelet Aggregates
|
15.53 %aggregation
Standard Error 1.28
|
15.43 %aggregation
Standard Error 2.07
|
13.15 %aggregation
Standard Error 1.15
|
14.96 %aggregation
Standard Error 1.33
|
16.03 %aggregation
Standard Error 1.47
|
14.85 %aggregation
Standard Error 0.85
|
SECONDARY outcome
Timeframe: 14 DaysSecondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function.
Outcome measures
| Measure |
Placebo Baseline
n=8 Participants
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Placebo Follow up
n=7 Participants
|
Aspirin Baseline
n=15 Participants
|
Aspirin Randomization
n=11 Participants
|
Clopidogrel Baseline
n=17 Participants
|
Clopidogrel Randomization
n=14 Participants
|
|---|---|---|---|---|---|---|
|
Percentage Leukocyte-Platelet Aggregate
|
14.06 %aggregation
Standard Error 1.24
|
13.84 %aggregation
Standard Error 1.97
|
11.18 %aggregation
Standard Error 0.90
|
12.11 %aggregation
Standard Error 1.01
|
13.06 %aggregation
Standard Error 0.83
|
12.29 %aggregation
Standard Error 0.88
|
Adverse Events
Placebo Baseline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Follow up
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin Randomization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidogrel Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidogrel Randomization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Baseline
n=10 participants at risk
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Placebo Follow up
n=9 participants at risk
|
Aspirin Baseline
n=14 participants at risk
|
Aspirin Randomization
n=13 participants at risk
|
Clopidogrel Baseline
n=21 participants at risk
|
Clopidogrel Randomization
n=16 participants at risk
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diverticulitis with mesenteric thrombophlebitis
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/21
|
0.00%
0/16
|
Other adverse events
| Measure |
Placebo Baseline
n=10 participants at risk
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
|
Placebo Follow up
n=9 participants at risk
|
Aspirin Baseline
n=14 participants at risk
|
Aspirin Randomization
n=13 participants at risk
|
Clopidogrel Baseline
n=21 participants at risk
|
Clopidogrel Randomization
n=16 participants at risk
|
|---|---|---|---|---|---|---|
|
General disorders
stomach irritation
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/21
|
0.00%
0/16
|
Additional Information
Jeffrey Berger, MD
New York University School of Medicine
Phone: 212 263 4004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place