Assessing blood tests to predict risks in kidney disease patients with heart issues
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
This study is testing new blood tests to see if they can help doctors better manage the risks of blood clots and bleeding in kidney disease patients who also have heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06026436 on ClinicalTrials.gov |
What this trial studies
This study aims to develop two biomarker assays to evaluate thrombotic and bleeding risks in patients with stage 3A or more severe chronic kidney disease who are undergoing treatment for acute coronary syndrome. The biomarkers include an active form of an intra-platelet molecule called Rap1b and the pro-antithrombotic balance of circulating endothelial microvesicles. By tailoring antiplatelet therapy based on these biomarkers, the study seeks to minimize the risks of thrombotic and hemorrhagic events in this vulnerable patient population. The research is part of a larger initiative focused on improving outcomes for chronic kidney disease patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with stage 3A or more severe chronic kidney disease experiencing acute coronary syndrome.
Not a fit: Patients with conditions other than chronic kidney disease or those not experiencing acute coronary syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and safer antiplatelet therapy for patients with chronic kidney disease and acute coronary syndrome.
How similar studies have performed: While similar approaches have been explored, this specific combination of biomarkers in chronic kidney disease patients with acute coronary syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man or woman ≥18 years old and \<90 * If the subject is a woman, she must be on contraception or menopausal. * Non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: (1) symptoms of myocardial ischemia, (2) electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or (3) an elevated cardiac troponin value (above the upper limit of normal) 56 or ST segment elevation ACS scheduled for primary PCI defined 57 as a history of chest discomfort or ischemic symptoms of \>20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one ECG: 1. ST-segment elevation ≥1 mm in two or more contiguous ECG leads 2. New or presumably new left bundle branch block (LBBB). 3. ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction * Subject intended for an invasive strategy if NSTE-ACS or primary PCI if STE-ACS according to guidelines (appendix X) * Subject with CKD stage 3A or higher (estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m2 according to the CKD-EPI formula * Because of the documented biological variability of eGRF levels, patients with a eGRF \< 78 ml/min/1.73 m2 can be included in this study, based on previous blood test results and on the investigator's decision. The DFG level of 78 ml/min/1.73 m2 correspond to an increase of 30 % of a DFG of 60 ml/min/1.73 m2. Indeed, the literature estimated a DFG levels variability of 30 % 58-61. * Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital. * Subject affiliated to or beneficiary of a social security system. * Subject having signed written informed consent. Exclusion Criteria: * \- Minors, pregnant or breast-feeding women; * Subject under chronic anticoagulant * Subject with thrombolytic therapy during the preceding 24 hours; * Subject with bleeding diathesis; * Subject not agreeing to participate. * Subject with contraindication to clopidogrel, ticagrelor or to another anti platelet agent. * Severe hepatic failure * Ischemic Stroke within one month or a history of hemorrhagic stroke * Platelet count\<100 000 * Major surgery or trauma within 10 days * Life expectancy \<1 year * Known significant bleeding risk according to the physician judgment * Adults subject to a legal protection measure or unable to express their consent (persons under guardianship, curatorship or safeguard of justice) * Persons deprived of their rights of liberty by judicial or administrative decision (persons in a situation of social fragility) * Progressive cancer * Systemic autoimmune disease * Chronic viral or bacterial infections * Diabetes requiring insulin therapy * Constitutional haemorrhagic syndrome * Organ transplantation
Where this trial is running
Marseille
- Assistance Publique Hopitaux de Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Laurent Bonello
- Email: laurent.bonello@ap-hm.fr
- Phone: 0491968858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.