Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02380391
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2015-02-24
Brief Title:
EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome STST- in HIV
Sponsor:
Saint Antoine University Hospital
Organization:
Saint Antoine University Hospital
Study Overview
Official Title:
EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome in HIV-infected Patients The EVERE2ST-HIV Study
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVERE2ST-HIV
Brief Summary:
Elevated on-treatment platelet reactivity is an independent risk factor of major adverse cardiovascular events following percutaneous coronary intervention or ACS People living with HIV patients have a higher risk of recurrent events after ACS than people without HIV
The investigators hypothesized that this increased risk is driven by higher platelet reactivity
Using a nested case-control study design HIV-infected and HIV-uninfected patients with a first episode of Acute Coronary Syndrome ACS treated with percutaneous coronary intervention were matched for age sex known diabetes mellitus and anti-platelet therapy
The primary end-point was the residual platelet reactivity RPA on dual antiplatelet therapy assessed by light transmission aggregometry LTA 20µM ADP
The study was conducted in a two large public university hospitals in central Paris France
The investigators hypothesized that this increased risk is driven by higher platelet reactivity
Using a nested case-control study design HIV-infected and HIV-uninfected patients with a first episode of Acute Coronary Syndrome ACS treated with percutaneous coronary intervention were matched for age sex known diabetes mellitus and anti-platelet therapy
The primary end-point was the residual platelet reactivity RPA on dual antiplatelet therapy assessed by light transmission aggregometry LTA 20µM ADP
The study was conducted in a two large public university hospitals in central Paris France
Detailed Description:
Study design
Research of routine care - hospital based two site nested case-control study conducted in the Institute of Cardiology within the Pitie-Salpetriere University Hospital and the Cardiac Center of the Saint Antoine University Hospital
Number of participants
Group 1 n80 HIV seropositive participants HIV Group 2 n160 HIV seronegative participants HIV- Sample size calculation based on 10 absolute difference between the two groups for maximum platelet aggregation MPA to residual platelet aggregation RPA ratio calculated MPARPA for each antiplatelet drug Aspirin Clopidogrel Prasugrel
Study justification
Platelet function is a risk marker independent of ACS recurrence risk People living with HIV who have a premature coronary artery disease revealed by an ACS event more frequently experience ischemic recurrence than people without HIV
Hypothesis
Due to their elevated residual platelet reactivity people living with HIV present more frequent ACS recurrence following a first event than people without HIV
Primary objective
Determine if there is an influence of HIV and antiretroviral medications on the platelet reactivity of individuals under oral antiplatelet treatment PLatelet reactivity will be assessed between one week to 3 years after the initial acute coronary syndrome under dual antiplatelet therapy
Methods
Platelet aggregation measured by
1 Light transmission aggregometry LTA 20µM adenosine diphosphate receptor inhibitor ADP and 5µM of arachidonic acid AA
2 Point of care VerifyNowRM P2Y12 and ARU P2Y12 Reaction Units and ARU Aspirin Reaction Units
3 Flow cytometry VAsodilatator Simulated Phosphoprotein VASP
Research of routine care - hospital based two site nested case-control study conducted in the Institute of Cardiology within the Pitie-Salpetriere University Hospital and the Cardiac Center of the Saint Antoine University Hospital
Number of participants
Group 1 n80 HIV seropositive participants HIV Group 2 n160 HIV seronegative participants HIV- Sample size calculation based on 10 absolute difference between the two groups for maximum platelet aggregation MPA to residual platelet aggregation RPA ratio calculated MPARPA for each antiplatelet drug Aspirin Clopidogrel Prasugrel
Study justification
Platelet function is a risk marker independent of ACS recurrence risk People living with HIV who have a premature coronary artery disease revealed by an ACS event more frequently experience ischemic recurrence than people without HIV
Hypothesis
Due to their elevated residual platelet reactivity people living with HIV present more frequent ACS recurrence following a first event than people without HIV
Primary objective
Determine if there is an influence of HIV and antiretroviral medications on the platelet reactivity of individuals under oral antiplatelet treatment PLatelet reactivity will be assessed between one week to 3 years after the initial acute coronary syndrome under dual antiplatelet therapy
Methods
Platelet aggregation measured by
1 Light transmission aggregometry LTA 20µM adenosine diphosphate receptor inhibitor ADP and 5µM of arachidonic acid AA
2 Point of care VerifyNowRM P2Y12 and ARU P2Y12 Reaction Units and ARU Aspirin Reaction Units
3 Flow cytometry VAsodilatator Simulated Phosphoprotein VASP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None