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Trial record 62 of 618 for:    ASPIRIN AND clopidogrel

Antiplatelet Therapy in HIV

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ClinicalTrials.gov Identifier: NCT02559414
Recruitment Status : Completed
First Posted : September 24, 2015
Results First Posted : September 11, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions HIV
Cardiovascular Diseases
Inflammation
Interventions Drug: Aspirin
Drug: Clopidogrel
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Aspirin Clopidogrel
Hide Arm/Group Description This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.

This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.

Aspirin

This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.

Clopidogrel

Period Title: Overall Study
Started 11 22 22
Completed 10 20 20
Not Completed 1 2 2
Reason Not Completed
Lost to Follow-up             0             1             0
Withdrawal by Subject             1             0             1
Other             0             1             1
Arm/Group Title Control Aspirin Clopidogrel Total
Hide Arm/Group Description This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.

This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.

Aspirin

This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.

Clopidogrel

Total of all reporting groups
Overall Number of Baseline Participants 11 22 22 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 22 participants 22 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
20
  90.9%
19
  86.4%
50
  90.9%
>=65 years
0
   0.0%
2
   9.1%
3
  13.6%
5
   9.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 22 participants 22 participants 55 participants
Female
6
  54.5%
7
  31.8%
10
  45.5%
23
  41.8%
Male
5
  45.5%
15
  68.2%
12
  54.5%
32
  58.2%
1.Primary Outcome
Title Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min
Hide Description 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.
Time Frame Baseline, 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Hide Arm/Group Description:
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 9 14 13 21 16
Mean (Standard Error)
Unit of Measure: %aggregation
72.35  (5.71) 79.11  (3.15) 72.79  (5.11) 26.77  (7.61) 71.07  (6.16) 65.00  (8.16)
2.Secondary Outcome
Title Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min
Hide Description [Not Specified]
Time Frame Baseline, 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Hide Arm/Group Description:
This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 9 14 13 21 16
Mean (Standard Error)
Unit of Measure: %aggregation
69.45  (9.04) 80.33  (2.77) 82.04  (2.44) 62.00  (5.50) 78.86  (3.45) 39.88  (7.95)
3.Secondary Outcome
Title Percentage Monocyte-Platelet Aggregates
Hide Description Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 9 14 13 21 16
Mean (Standard Error)
Unit of Measure: %aggregation
69.45  (9.04) 80.33  (2.77) 82.04  (2.44) 62.00  (5.50) 78.86  (3.45) 39.88  (7.95)
4.Secondary Outcome
Title Percentage Monocyte-Platelet Aggregates
Hide Description Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Follow up Clopidogrel Baseline Clopidogrel Follow up
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 7 10 8 16 13
Mean (Standard Error)
Unit of Measure: %aggregation
15.53  (1.28) 15.43  (2.07) 13.15  (1.15) 14.96  (1.33) 16.03  (1.47) 14.85  (0.85)
5.Secondary Outcome
Title Percentage Leukocyte-Platelet Aggregate
Hide Description Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function.
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 7 15 11 17 14
Mean (Standard Error)
Unit of Measure: %aggregation
14.06  (1.24) 13.84  (1.97) 11.18  (0.90) 12.11  (1.01) 13.06  (0.83) 12.29  (0.88)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Hide Arm/Group Description This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication. [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/9 (0.00%)      0/14 (0.00%)      0/13 (0.00%)      0/21 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/9 (11.11%)      0/14 (0.00%)      0/13 (0.00%)      0/21 (0.00%)      0/16 (0.00%)    
Gastrointestinal disorders             
Diverticulitis with mesenteric thrombophlebitis  [1]  0/10 (0.00%)  0 1/9 (11.11%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0 0/21 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
The subject's symptoms occurred after enrollment, but well before study drug administration.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Baseline Placebo Follow up Aspirin Baseline Aspirin Randomization Clopidogrel Baseline Clopidogrel Randomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/9 (0.00%)      0/14 (0.00%)      0/13 (0.00%)      0/21 (0.00%)      0/16 (0.00%)    
General disorders             
stomach irritation   1/10 (10.00%)  1 0/9 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/21 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Berger, MD
Organization: New York University School of Medicine
Phone: 212 263 4004
EMail: Jeffrey.Berger@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02559414     History of Changes
Other Study ID Numbers: 14-02104
First Submitted: March 10, 2015
First Posted: September 24, 2015
Results First Submitted: August 8, 2017
Results First Posted: September 11, 2017
Last Update Posted: October 15, 2018