ACETYLSALICYLIC ACID for ST elevation myocardial infarction (STEMI)

Inclusion criteria

• {"criterion_text":"- Clinical and electrocardiographical diagnosis of STEMI"}
• {"criterion_text":"- Successful PCI (according to the treating physician) of the infarct-related vessel with a modern DES"}

Exclusion criteria

• {"criterion_text":"- Known allergy or contraindication for aspirin, ticagrelor or prasugrel."}
• {"criterion_text":"- PCI of stent thrombosis"}
• {"criterion_text":"- Suboptimal stent result as judged by the interventional cardiologist"}
• {"criterion_text":"- Life expectancy shorter than 13 months"}
• {"criterion_text":"- Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population)"}
• {"criterion_text":"- Previous PCI or MI less than 12 months ago"}
• {"criterion_text":"- Previous cardiac surgery"}
• {"criterion_text":"- Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))"}
• {"criterion_text":"- Pregnancy and breast feeding"}
• {"criterion_text":"- Concurrent use of oral anticoagulants (OAC)"}
• {"criterion_text":"- The periprocedural use of GPIIb/IIIa inhibitors"}
• {"criterion_text":"- Planned surgical intervention within 12 months of PCI"}
• {"criterion_text":"- Creatinine clearance <30 mL/min or dialysis"}

Primary endpoints

• {"endpoint_text":"- Composite of major adverse cardiac and cerebral events (MACCE), consisting of: Myocardial infarction; Stent thrombosis; Ischemic stroke;Cardiovascular mortality.","definition_or_measurement_approach":"Composite endpoint consisting of occurrence of myocardial infarction, stent thrombosis, ischemic stroke, or cardiovascular mortality (components listed in the endpoint)."}
• {"endpoint_text":"- Infarct size and size of IMH determined by CMR at day 5-8 post-PPCI.","definition_or_measurement_approach":"Measured by cardiac magnetic resonance imaging (CMR) at day 5-8 after primary PCI to determine infarct size and extent of intramyocardial haemorrhage (IMH)."}

Secondary endpoints

• {"endpoint_text":"- Bleeding complications BARC ≥ 2","definition_or_measurement_approach":"Bleeding classified using the BARC (Bleeding Academic Research Consortium) scale; events of grade ≥2 counted."}
• {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":"Death from any cause."}
• {"endpoint_text":"- To compare platelet reactivity between ticagrelor monotherapy and ticagrelor + ASA.","definition_or_measurement_approach":"Comparison of platelet reactivity between treatment arms (method not specified in the record)."}
• {"endpoint_text":"- To assess the anti-inflammatory effects of ticagrelor with or without aspirin on the inflammation response elicited by the myocardial infarction.","definition_or_measurement_approach":"Assessment of anti-inflammatory effects (specific biomarkers or methods not specified in the record)."}
• {"endpoint_text":"- To assess coagulation factors after the myocardial infarction in patients using ticagrelor with or without aspirin.","definition_or_measurement_approach":"Assessment of coagulation factors post-MI (specific assays not specified in the record)."}

Netherlands

Earliest CTIS Part Ii Submission Date

17-09-2024

Latest Decision Or Authorization Date

20-09-2024

Processing Time Days

3

Number Of Sites

5

Number Of Participants

200

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands