Actively Recruiting
Evaluation of Platelet-based and Microvesicle-based Tests to Predict Clotting and Bleeding Risks 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two new biomarker tests to better predict blood clotting and bleeding risks in adults with stage 3A or more severe chronic kidney disease (CKD) who have experienced an acute coronary syndrome (ACS) and undergone percutaneous coronary intervention (PCI). The study aims to improve how antiplatelet therapy is tailored for each patient to reduce these risks. This project is part of the RHU INNOV-CKD initiative and involves collaboration with industry partners to develop automated methods for measuring these biomarkers. The study involves collecting blood samples at specific times: 12 to 24 hours after a P2Y12 ADP receptor loading dose and again one month after PCI. These tests focus on two biomarkers: active Rap1b in platelets and the pro-antithrombotic balance of circulating endothelial microvesicles, which reflect how well the blood vessels are functioning. These measurements will be used to assess the risk of clotting and bleeding. Participants will be monitored over time, with the main outcome being how well high levels of active Rap1b predict risk at 12 months. Additional measurements of the biomarkers will be taken at 1 and 6 months to track changes. Throughout the study, researchers will evaluate these markers to understand their relationship with thrombotic and hemorrhagic events, aiming to improve personalized treatment. The study is expected to continue until December 2026.
CONDITIONS
Brief 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...
- Men or women aged 18 years or older and younger than 90 years
- Women must be using contraception or be menopausal
- Diagnosis of non-ST-segment elevation acute coronary syndrome with at least two specific clinical or ECG criteria, or ST segment elevation ACS scheduled for primary PCI
- Planned invasive treatment strategy for NSTE-ACS or primary PCI for STE-ACS according to guidelines
- Chronic kidney disease stage 3A or higher with estimated glomerular filtration rate (eGFR) \u2264 60 ml/min/1.73 m2
- Patients with eGFR up to 78 ml/min/1.73 m2 may be included based on previous tests and investigator decision
- Enrollment at a cardiac catheterization center or affiliated hospital
- Affiliation to 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 past 24 hours
- Bleeding disorders
- Refusal to participate
- Contraindication 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
- Known significant bleeding risk according to physician judgment
- Legal protection measures preventing consent
- Persons deprived of liberty by legal or administrative decision
- Progressive cancer
- Systemic autoimmune disease
- Chronic viral or bacterial infections
- Diabetes requiring insulin therapy
- Constitutional hemorrhagic syndrome
- Organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants provide blood samples to assess clotting and bleeding risks after intervention.
2 visits: 12-24 hours after P2Y12 ADP receptor loading dose and 1 month after Percutaneous Coronary Intervention (PCI)
Trial Site Locations
Total: 1 location
1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Actively Recruiting
Research Team
L
LAURENT BONELLO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here