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RECRUITING
NCT06026436
NA

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

850

Start Date

2023-10-12

Completion Date

2026-12

Last Updated

2023-10-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

Blood samples

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

BIOLOGICAL

Blood samples

1 month after Percutaneous Coronary Intervention (PCI)

Locations (1)

Assistance Publique Hopitaux de Marseille

Marseille, France