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Tests treatment safety and results for Chronic Kidney Disease stage3
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
ClinicalTrials.gov ID: NCT06026436
What this study is testing
What is Blood samples?
Blood samples is an investigational medicine, being studied as a potential treatment for chronic kidney disease stage3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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)...
- ST-segment elevation ≥1 mm in two or more contiguous ECG leads
- New or presumably new left bundle branch block (LBBB).
You likely can't join if
- \- 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.
See the full eligibility 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...
- ST-segment elevation ≥1 mm in two or more contiguous ECG leads
- New or presumably new left bundle branch block (LBBB).
- 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...
- 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.
- \- 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
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.