Clinical trial NCT02380391: EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome (ST+/ST-) in HIV
Official title: EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome in HIV-infected Patients. The EVERE2ST-HIV Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
HIV
Keywords: Platelet reactivity
Acute coronary syndrome
Antiplatelet treatment
Antiretroviral treatment
HIV
Lead sponsor: Saint Antoine University Hospital
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
First posted: 2015-03-05
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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 : 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 :

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))

Eligibility criteria: INCLUSION CRITERIA :

HIV+ group

* HIV-1 seropositive, known for a minimum of 6 months
* 18 years of age or older
* Hospitalisation for acute coronary syndrome a minimum of one month prior to inclusion (with or without coronary revascularisation)
* Under any antiplatelet therapy
* Willing and able to give informed consent to participate in the study

HIV- group

* HIV seronegative
* 18 years of age or older
* Hospitalisation for acute coronary syndrome a minimum of one month prior to inclusion (with or without coronary revascularisation)
* Under any antiplatelet therapy
* Willing and able to give informed consent to participate in the study

EXCLUSION CRITERIA :

* Refusal to give or sign informed consent
* Presence of a counterindication or non-indication for antiplatelet therapy
* Not associated with a social security regime (no health insurance)

Primary outcomes:
measure: Residual platelet reactivity (measure 1). measured by light transmission aggregometry following stimulation by 20µM of ADP.
timeFrame: betwwen one week to 3 years
Secondary outcomes:
measure: Residual platelet reactivity (measure 2). measured by light transmission aggregometry following stimulation by 5µM of arachidonic acid
timeFrame: betwwen one week to 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Cardiology department
Study officials:
affiliation: Saint Antoine University Hospital
name: Franck Boccara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Antoine University Hospital
name: Ariel Cohen, MD, PhD
role: STUDY_DIRECTOR
affiliation: ACTION Study Group, Unité de Recherche Clinique-Hôpital Lariboisière (APHP) and Université Paris 6, INSERM, Paris, France
name: Jean Philippe Collet, MD, PhD
role: STUDY_DIRECTOR
affiliation: ACTION Study Group, Unité de Recherche Clinique-Hôpital Lariboisière (APHP) and Université Paris 6, INSERM, Paris, France
name: Johanne Silvain, MD, PhD
role: STUDY_DIRECTOR
affiliation: ACTION Study Group, Unité de Recherche Clinique-Hôpital Lariboisière (APHP) and Université Paris 6, INSERM, Paris, France
name: Gilles Montalescot, MD, PhD
role: STUDY_CHAIR
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