CLOPIDOGREL for Non-ST-elevation acute coronary syndrome | Coronary artery disease

Inclusion criteria

• {"criterion_text":"- Age 18 or older"}
• {"criterion_text":"- Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)"}
• {"criterion_text":"- Successful PCI (according to the treating physician)"}
• {"criterion_text":"- CYP2C19 extensive or ultra-rapid metabolizer"}

Exclusion criteria

• {"criterion_text":"- CYP2C19 poor or intermediate metabolizer"}
• {"criterion_text":"- Planned surgical intervention within 6 months of PCI"}
• {"criterion_text":"- Pregnant or breastfeeding women at time of enrolment"}
• {"criterion_text":"- Participation in another trial with an investigational drug or device"}
• {"criterion_text":"- Known allergy or contraindication for aspirin or clopidogrel."}
• {"criterion_text":"- Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)"}
• {"criterion_text":"- Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)"}
• {"criterion_text":"- High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, ≥3 treated vessels, ≥ 3 stents implanted and total stent length >60 mm"}
• {"criterion_text":"- Recent stroke, transient ischemic attack (TIA) or intracranial bleeding"}
• {"criterion_text":"- Severe hepatic impairment (Child Pugh class C)"}

Primary endpoints

• {"endpoint_text":"- The primary ischemic endpoints at 6 months is the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, and ischemic stroke","definition_or_measurement_approach":"Composite ischemic endpoint assessed at 6 months comprising all-cause mortality, myocardial infarction, definite or probable stent thrombosis, and ischemic stroke."}
• {"endpoint_text":"- The primary bleeding endpoint at 6 months is major or minor bleeding (BARC type 2, 3 or 5 bleeding)","definition_or_measurement_approach":"Bleeding events assessed at 6 months using BARC classification; primary bleeding endpoint includes BARC type 2, 3 or 5 bleeding."}

Secondary endpoints

• {"endpoint_text":"- Primary ischemic and bleeding endpoint at 1 month","definition_or_measurement_approach":"Assessment of the primary ischemic and bleeding composite endpoints at 1 month."}
• {"endpoint_text":"- Each individual component of the primary endpoints at 1 and 6 months","definition_or_measurement_approach":"Individual components (e.g., all-cause mortality, MI, stent thrombosis, ischemic stroke, and bleeding categories) assessed at 1 and 6 months."}
• {"endpoint_text":"- Cardiovascular mortality at 1 and 6 months.","definition_or_measurement_approach":"Cardiovascular death assessed at 1 and 6 months."}
• {"endpoint_text":"- Non-cardiovascular mortality at 1 and 6 months.","definition_or_measurement_approach":"Non-cardiovascular death assessed at 1 and 6 months."}
• {"endpoint_text":"- Any need for revascularization at 1 and 6 months.","definition_or_measurement_approach":"Occurrence of any revascularization procedures assessed at 1 and 6 months."}
• {"endpoint_text":"- Any periprocedural complications.","definition_or_measurement_approach":"Assessment and recording of any procedural complications related to PCI."}

Netherlands

Earliest CTIS Part Ii Submission Date

08-10-2024

Latest Decision Or Authorization Date

26-11-2024

Processing Time Days

49

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Sint Antonius Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands