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Trial record 63 of 621 for:    ASPIRIN AND clopidogrel

Antiplatelet Therapy in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 10, 2015
First Posted Date  ICMJE September 24, 2015
Results First Submitted Date  ICMJE August 8, 2017
Results First Posted Date  ICMJE September 11, 2017
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min [ Time Frame: Baseline, 14 Days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Platelet Activity as measured by the change in biomarkers from baseline to follow-up identified via light-transmitted aggregometry and flow cytometry. [ Time Frame: 14 Days ]
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.
Change History Complete list of historical versions of study NCT02559414 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min [ Time Frame: Baseline, 14 Days ]
  • Percentage Monocyte-Platelet Aggregates [ Time Frame: 14 Days ]
    Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation
  • Percentage Monocyte-Platelet Aggregates [ Time Frame: 14 Days ]
    Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity
  • Percentage Leukocyte-Platelet Aggregate [ Time Frame: 14 Days ]
    Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • Inflammation as measured by the change in biomarkers from baseline to follow-up identified via flow cytometry and hematological analysis. [ Time Frame: 14 Days ]
    Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation
  • Immune Activity as Measured by the Change in Biomarkers From Baseline to Follow-up Identified Via Flow Cytometry and Hematological Analysis. [ Time Frame: 14 Days ]
    Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity
  • Endothelial Function as Measured by Its Change From Baseline to Follow-up in Activation Following the Co-culture of Platelets With Human Endothelial Cells, and the Extraction of mRNA From Human Endothelial Cells by Polymerase Chain Reaction. [ Time Frame: 14 Days ]
    Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiplatelet Therapy in HIV
Official Title  ICMJE Antiplatelet Therapy in HIV - Antiplatelet and Immune Modulating Effects of Aspirin or Clopidogrel in Subjects With HIV
Brief Summary The proposed study will add to the growing understanding of platelet activity and platelet inhibition in subjects with HIV. It will examine the relationship between platelet activity and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy) in this high-risk cohort. Furthermore, it will provide important data on the mechanism of platelet activity and its inhibition using biomarkers of platelet activity, inflammation, immune activity and endothelial function and genetic expression profiling.
Detailed Description

There is substantial evidence that the risk of serious non-AIDS conditions, such as cardiovascular disease, kidney disease, liver disease, and non-AIDS-defining malignancies, is increased in persons with HIV infection as compared to the general population. HIV-induced activation of inflammatory and coagulation pathways have been implicated in this increased risk. However, causative mechanisms linking HIV, inflammation, and increased risk of non-AIDS diseases are poorly described. The investigators are interested in studying the link between HIV induced inflammation and cardiovascular disease. Inflammation mediates many aspects of disease pathogenesis in atherosclerosis, involving diverse cell types and mediating signals. Specifically, platelets have been implicated in atherosclerosis because of their pro-inflammatory and thrombogenic effects. Moreover, clinical studies have demonstrated the importance of platelet activity in coronary artery atherosclerosis and thrombosis. Whereas there is a great understanding of the pathogenesis of cardiac disease, there is a wide knowledge gap in the understanding of mechanisms of cardiovascular disease in patients with HIV.

A recent study by the investigators demonstrated that platelet activity is heightened in subjects with HIV. Following 1-week of low-dose aspirin, platelet activity was inhibited. A surprising finding of this study demonstrated that antiplatelet therapy with 1 week of aspirin (325mg dose x1 day followed by 81mg daily) improved immune activity in subjects with HIV. The current study is being performed to replicate those findings when compared with a control group. Moreover, it remains unknown if the finding was specific to aspirin or whether the results were attributed to the antiplatelet effect of the drug. Clopidogrel is another antiplatelet therapy that targets the P2Y12 receptor (a different mechanism than aspirin) that has been shown to lower the risk of cardiovascular events in various clinical settings. The doses of aspirin and clopidogrel the investigators will be employing have been tested in hundreds of studies with well-known benefits and risks. The investigators believe that understanding the mechanistic role of platelet inhibitors in the setting of HIV will help uncover a new strategic pathway of HIV pathogenesis. Also, subjects with HIV are at increased risk for cardiovascular events and understanding the platelet inhibition of aspirin and clopidogrel will help establish better designs for future trials aimed at preventing these events in HIV infected persons.

The investigators have demonstrated that platelet activation is increased in HIV infection and can be attenuated by low-dose aspirin in a non-randomized study without a control group. Therefore, the Specific Aims of the study to be established are as follows:

  • The effect of aspirin versus control on markers of platelet activity, inflammation, immune activity, and endothelial function.
  • The effect of Clopidogrel versus control on markers of platelet activity, inflammation, immune activity, and endothelial function.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • Cardiovascular Diseases
  • Inflammation
Intervention  ICMJE
  • Drug: Aspirin
  • Drug: Clopidogrel
Study Arms  ICMJE
  • No Intervention: Control
    This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.
  • Active Comparator: Aspirin
    This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.
    Intervention: Drug: Aspirin
  • Active Comparator: Clopidogrel
    This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.
    Intervention: Drug: Clopidogrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
55
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
50
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV infection
  • Current Antiretroviral Therapy with no change in regimen in the 12 weeks prior to study entry and no plans to change ART for the study duration
  • Ability to sign consent and comply with the protocol

Exclusion Criteria:

  • Known CD4+ T cell counts < 200 cells/mm3 during the 6 months prior to study entry
  • Established cardiovascular disease (thereby necessitating antiplatelet therapy)
  • NSAID use in the past week (including aspirin)
  • Unable to be off NSAIDs for the duration of the trial
  • Any antiplatelet or antithrombotic use
  • Allergy to aspirin or clopidogrel
  • Pregnancy
  • Chronic kidney disease (GFR<45 ml/min)
  • AIDS
  • Active drug or alcohol use that would interfere with adherence to study requirements
  • Any known bleeding disorder
  • Use of regularly prescribed medication such as steroids, or immunosuppressive agents
  • Known anemia (Hb <8mg/dL)
  • Thrombocytopenia (platelet count <75) or thrombocytosis (Platelet count >600)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02559414
Other Study ID Numbers  ICMJE 14-02104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey S Berger, MD NYU School of Medicine
PRS Account NYU Langone Health
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP