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

Korábbi kezelés

• Subject with thrombolytic therapy during the preceding 24 hours;
• Major surgery or trauma within 10 days
• Organ transplantation

Más betegség

• Subject with bleeding diathesis;
• Severe hepatic failure
• Ischemic Stroke within one month or a history of hemorrhagic stroke
• Known significant bleeding risk according to the physician judgment
• Progressive cancer
• Systemic autoimmune disease
• Chronic viral or bacterial infections
• Diabetes requiring insulin therapy
• Constitutional haemorrhagic syndrome

Laborértékek

• Subject with contraindication to clopidogrel, ticagrelor or to another anti platelet agent.
• Platelet count<100 000

Egyéb

• - Minors, pregnant or breast-feeding women;
• Subject under chronic anticoagulant
• Subject not agreeing to participate.
• Life expectancy <1 year
• 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)

• 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:
  • 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 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.