Status:
COMPLETED
TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome.
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as first-line agent in ACS (2). This drug was associated with a 20% relative reduction in the rate of MACE in ACS patie...
Eligibility Criteria
Inclusion
- \- Must not be of child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile).
- 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) (2) or ST segment elevation ACS scheduled for primary PCI defined (22)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 prior to randomization:
- 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 (annexe 1)
- Subject CKD stage 4 and 5 (estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m2 by (MDRD formula) or undergoing chronic dialysis
- 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
- Minors, pregnant or breast-feeding women;
- Subject under chronic anticoagulant
- Subject with thrombolytic therapy during the preceding 24 hours;
- Subject with bleeding ;
- Subject participating in another research protocol;
- Subject not agreeing to participate.
- Subject with contraindication to clopidogrel or ticagrelor
- Severe hepatic failure
- Ischemic Stroke within one month or a history of hemorrhagic stroke
- Bradycardia
- Platelet count\<100 000
- Major surgery or trauma within 10 days
- Life expectancy \<1 year
- Known significant bleeding risk according to the physician judgment
Key Trial Info
Start Date :
October 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2023
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT03357874
Start Date
October 28 2018
End Date
July 18 2023
Last Update
June 27 2025
Active Locations (1)
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1
APHM
Marseille, France, 13354