RecruitingNot ApplicableNCT06026436

Evaluation of the Effectiveness of Platelet-based and Microvesicle-based Assays to Predict Thrombotic and Bleeding Risk in Chronic Kidney Disease Patients With Acute Coronary Syndrome


Sponsor

Assistance Publique Hopitaux De Marseille

Enrollment

850 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is part of the RHU INNOV-CKD, winner of the 2019 call for projects. Its aim is to develop two biomarker assays to assess the thrombotic and haemorrhagic risks in patients with stage 3A or more severe chronic kidney disease (CKD) treated with percutaneous coronary intervention (PCI) and antiplatelet therapy following an acute coronary syndrome (ACS). We believe that these tests will help to adapt antiplatelet therapy on an individual basis (in terms of intensity and duration of treatment) and thus reduce the risk of thrombotic and haemorrhagic events in this particularly fragile population. The first biomarker corresponds to an intra-platelet molecule, Rap1b in its active form (known as aRap1b). The second is the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), which reflects endothelial dysfunction. An automated method for measuring these biomarkers will be developed in partnership with the D.Stago and BioCytex industries during the course of the project.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at blood tests in patients with both chronic kidney disease (CKD) and a recent heart attack or acute coronary syndrome (ACS), to better predict who is at risk for blood clots or dangerous bleeding. Kidney disease affects how blood clots, making treatment decisions tricky — this research aims to improve that. **You may be eligible if...** - You are between 18 and 90 years old - You have been diagnosed with acute coronary syndrome (heart attack or unstable chest pain requiring urgent care) - You have chronic kidney disease (eGFR at or below 60) - You are being treated at a hospital with a cardiac catheterization lab **You may NOT be eligible if...** - You are under 18, pregnant, or breastfeeding - You are already on long-term blood thinners (anticoagulants) - You have had a stroke or serious bleeding event recently - You have progressive cancer, severe liver failure, or an organ transplant - Your platelet count is very low or you have a bleeding disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBlood samples

12-24 hours after P2Y12 ADP receptor loading dose (LD)

BIOLOGICALBlood samples

1 month after Percutaneous Coronary Intervention (PCI)


Locations(1)

Assistance Publique Hopitaux de Marseille

Marseille, France

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NCT06026436


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