Actively Recruiting
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
Led by Assistance Publique Hopitaux De Marseille · Updated on 2023-10-27
850
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman aged 18 years or older and younger than 90 years
- Women must be using contraception or be menopausal
- Non-ST-segment elevation ACS defined by at least 2 of the following: myocardial ischemia symptoms, ECG ST-segment abnormalities or T-wave inversion in 2 contiguous leads, or elevated cardiac troponin
- ST-segment elevation ACS scheduled for primary PCI with chest discomfort or ischemic symptoms >20 minutes within 14 days and specific ECG criteria
- Planned invasive strategy if NSTE-ACS or primary PCI if STE-ACS according to guidelines
- Chronic kidney disease stage 3A or higher with estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m2
- Patients with eGFR < 78 ml/min/1.73 m2 may be included based on previous results and investigator decision
- Enrollment at a cardiac catheterization laboratory hospital or affiliated center
- Affiliated with or beneficiary of a social security system
- Signed written informed consent
You will not qualify if you...
- Minors, pregnant or breastfeeding women
- Use of chronic anticoagulant therapy
- Thrombolytic therapy within the previous 24 hours
- Bleeding diathesis
- Refusal to participate
- Contraindications to clopidogrel, ticagrelor, or other antiplatelet agents
- Severe liver failure
- Ischemic stroke within one month or history of hemorrhagic stroke
- Platelet count below 100,000
- Major surgery or trauma within 10 days
- Life expectancy less than 1 year
- Significant bleeding risk as judged by physician
- Under legal protection or unable to consent
- Loss of liberty by judicial or administrative decision
- Progressive cancer
- Systemic autoimmune disease
- Chronic viral or bacterial infections
- Diabetes requiring insulin therapy
- Constitutional hemorrhagic syndrome
- Organ transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Actively Recruiting
Research Team
L
LAURENT BONELLO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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