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

HIV Clinical Trial

— EVERE2ST-HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380391
• Other study ID #: EVERE2ST-HIV
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: February 28, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Saint Antoine University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• HIV
• Syndrome

Locations

Country	Name	City	State
France	Cardiology department	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Saint Antoine University Hospital	Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

References & Publications (28)

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Hulot JS, Collet JP, Cayla G, Silvain J, Allanic F, Bellemain-Appaix A, Scott SA, Montalescot G. CYP2C19 but not PON1 genetic variants influence clopidogrel pharmacokinetics, pharmacodynamics, and clinical efficacy in post-myocardial infarction patients. Circ Cardiovasc Interv. 2011 Oct 1;4(5):422-8. doi: 10.1161/CIRCINTERVENTIONS.111.963025. Epub 2011 Oct 4. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No