Prasugrel for Acute coronary syndrome | Chronic coronary syndrome

Inclusion criteria

• {"criterion_text":"- Acute coronary intervention"}
• {"criterion_text":"- Chronic coronary syndrome"}
• {"criterion_text":"- Successfull PCI (according tot treating physician)"}

Exclusion criteria

• {"criterion_text":"- Known allergy or contraindication for prasugrel (including active pathological bleeding, severe liver disease (defined as Child Pugh class C))"}
• {"criterion_text":"- Current indication for oral anticoagulant therapy (OAC)"}
• {"criterion_text":"- Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)"}
• {"criterion_text":"- Pregnancy or breast-feeding women"}
• {"criterion_text":"- Participation in another trial with an investigational drug or device"}
• {"criterion_text":"- Recent or ongoing use of CYP2B6 substrates with a narrow therapeutic window"}

Primary endpoints

• {"endpoint_text":"- Net Adverse Clinical Events (NACE), a composite of all-cause mortality, myocardial infarction, definite stent thrombosis, ischemic stroke, major bleeding or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5","definition_or_measurement_approach":"Composite of all-cause mortality, myocardial infarction, definite stent thrombosis, ischemic stroke, major bleeding or clinically relevant non-major bleeding; bleeding defined according to BARC type 2, 3 or 5."}

Secondary endpoints

• {"endpoint_text":"- Treatment satisfaction, based on the Treatment Satisfaction Questionnaire for Medication II (TSQM-II)","definition_or_measurement_approach":"Measured using the Treatment Satisfaction Questionnaire for Medication II (TSQM-II)."}
• {"endpoint_text":"- Treatment adherence, based on the Morisky Medication Adherence Scale (MMAS-8)","definition_or_measurement_approach":"Measured using the Morisky Medication Adherence Scale (MMAS-8)."}
• {"endpoint_text":"- Each individual component of the primary endpoint","definition_or_measurement_approach":"Each component of the NACE composite (e.g., all-cause mortality, MI, stent thrombosis, ischemic stroke, major bleeding, clinically relevant non-major bleeding) evaluated separately."}
• {"endpoint_text":"- Cardiovascular mortality","definition_or_measurement_approach":""}
• {"endpoint_text":"- Non-cardiovascular mortality","definition_or_measurement_approach":""}
• {"endpoint_text":"- Any need for revascularization","definition_or_measurement_approach":""}
• {"endpoint_text":"- Major or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5","definition_or_measurement_approach":"Bleeding events classified according to BARC type 2, 3 or 5."}
• {"endpoint_text":"- Minor or clinically relevant non-major bleeding defined as BARC type 2 at 1, 6 and 12 month(s)","definition_or_measurement_approach":"Bleeding events classified according to BARC type 2 assessed at 1, 6 and 12 months."}
• {"endpoint_text":"- Any periprocedural complications","definition_or_measurement_approach":""}
• {"endpoint_text":"- On-treatment platelet reactivity at week 2 in the first 40 patients","definition_or_measurement_approach":"Platelet reactivity measured at week 2 in the first 40 patients (method not specified here)."}
• {"endpoint_text":"- Non-adherence to antiplatelet regimen","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

08-07-2025

Latest Decision Or Authorization Date

09-10-2025

Processing Time Days

93

Number Of Sites

2

Number Of Participants

300

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands