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Completed

NCT Number: NCT02380391

EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome (ST+/ST-) in HIV

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology department

Paris, 75012, France

About this study

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 :

  • Light transmission aggregometry (LTA, 20µM adenosine diphosphate receptor inhibitor (ADP) and 5µM of arachidonic acid (AA))
  • Point of care VerifyNowRM P2Y12 and ARU (P2Y12 Reaction Units and ARU Aspirin Reaction Units)
  • Flow cytometry (VAsodilatator Simulated Phosphoprotein (VASP))

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Residual platelet reactivity (measure 1). measured by light transmission aggregometry following stimulation by 20µM of ADP.

    Time frame: betwwen one week to 3 years

    Residual platelet reactivity under antiplatelet therapy measured by light transmission aggregometry following stimulation by 20µM of ADP.

Secondary outcomes

  1. Residual platelet reactivity (measure 2). measured by light transmission aggregometry following stimulation by 5µM of arachidonic acid

    Time frame: betwwen one week to 3 years

    Residual platelet reactivity under aspirin measured by light transmission aggregometry following stimulation by 5µM of arachidonic acid.

Sponsors and collaborators

Lead sponsor

Saint Antoine University Hospital

Other

Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

Registry information

Official study title

EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome in HIV-infected Patients. The EVERE2ST-HIV Study.

Acronym: EVERE2ST-HIV

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2015
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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