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

NCT02380391 | Completed DMC

• 1 other identifier: EVERE2ST-HIV
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; HIV

Keywords

Platelet reactivity; Acute coronary syndrome; Antiplatelet treatment; Antiretroviral treatment; HIV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  betwwen one week to 3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HIV+ group
• HIV-1 seropositive, known for a minimum of 6 months
• years of age or older
• Under any antiplatelet therapy
• Willing and able to give informed consent to participate in the study
• HIV- group
• HIV seronegative
• years of age or older
• Under any antiplatelet therapy
• Willing and able to give informed consent to participate in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saint Antoine University Hospital: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator

Study Sites (1)

Cardiology department

Paris, 75012, France

Location

Related Publications (28)

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  BACKGROUND

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Biospecimen

Retention: SAMPLES WITH DNA

Each blood sample is composed of 5 tubes, for a total volume of 25 ml of blood : * 1 x 4.5 ml citrated tube : standard light transmission aggregometry * 1 x 4.5 ml citrated tube : Bedside test VerifyNow * 2 x 4.5 ml citrated tubes : flow cytometry * 1 x 7 ml EDTA tube : genetic analysis of cytochrome P450 2C19 Blood samples do not require fasting.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 5, 2015
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-02

Locations

FR (1)