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| Name | Class |
|---|---|
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
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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.
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 : n=80 HIV seropositive participants (HIV+) Group 2 : n=160 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 MPA/RPA 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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People living with HIV (HIV+) | Adults experiencing first episode of ACS treated with percutaneous coronary intervention. | ||
| People without HIV (HIV-) | Adults experiencing first episode of ACS treated with percutaneous coronary intervention, matched to HIV+ on age, sex, known diabetes mellitus, and anti-platelet therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Residual platelet reactivity (measure 1). measured by light transmission aggregometry following stimulation by 20µM of ADP. | Residual platelet reactivity under antiplatelet therapy measured by light transmission aggregometry following stimulation by 20µM of ADP. | betwwen one week to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Residual platelet reactivity (measure 2). measured by light transmission aggregometry following stimulation by 5µM of arachidonic acid | Residual platelet reactivity under aspirin measured by light transmission aggregometry following stimulation by 5µM of arachidonic acid. | betwwen one week to 3 years |
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INCLUSION CRITERIA :
HIV+ group
HIV- group
EXCLUSION CRITERIA :
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Adults with a history of acute coronary syndrome (at least one month before inclusion) with or without coronary revascularization and under any antiplatelet therapy.
Controls matched on age (±5 years), sex, and known diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Franck Boccara, MD, PhD | Saint Antoine University Hospital | Principal Investigator |
| Ariel Cohen, MD, PhD | Saint Antoine University Hospital | Study Director |
| Jean Philippe Collet, MD, PhD | ACTION Study Group, Unité de Recherche Clinique-Hôpital Lariboisière (APHP) and Université Paris 6, INSERM, Paris, France | Study Director |
| Johanne Silvain, MD, PhD | ACTION Study Group, Unité de Recherche Clinique-Hôpital Lariboisière (APHP) and Université Paris 6, INSERM, Paris, France | Study Director |
| Gilles Montalescot, MD, PhD | ACTION Study Group, Unité de Recherche Clinique-Hôpital Lariboisière (APHP) and Université Paris 6, INSERM, Paris, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology department | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21934054 | Background | Parodi G, Marcucci R, Valenti R, Gori AM, Migliorini A, Giusti B, Buonamici P, Gensini GF, Abbate R, Antoniucci D. High residual platelet reactivity after clopidogrel loading and long-term cardiovascular events among patients with acute coronary syndromes undergoing PCI. JAMA. 2011 Sep 21;306(11):1215-23. doi: 10.1001/jama.2011.1332. | |
| 20965887 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 16, 2023 | |
| Reset | Jan 12, 2024 | |
| Release | Jan 28, 2024 | |
| Reset | Jul 17, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 16, 2023 | Jan 12, 2024 | |||
| Jan 28, 2024 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Each blood sample is composed of 5 tubes, for a total volume of 25 ml of blood :
Blood samples do not require fasting.
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| Jul 17, 2024 |