D,L-LYSINE ACETYLSALICYLATE for Chronic total occlusion of coronary artery

Inclusion criteria

• {"criterion_text":"- Patients who underwent a successful coronary stent implantation for chronic coronary occlusion"}
• {"criterion_text":"- Affiliated to Social Security system"}
• {"criterion_text":"- Signature of informed consent"}
• {"criterion_text":"- Age > 18 years old"}

Exclusion criteria

• {"criterion_text":"- Dual antiplatelet therapy contra-indication"}
• {"criterion_text":"- Patient with hypersensitivity to aspirin (or any of its excipients) and/or to any of the active substance or to any of the excipients of the investigational medical product used in this study (clopidogrel)"}
• {"criterion_text":"- Patient with contraindication to aspirin and/or clopidogrel"}
• {"criterion_text":"- No coronary stent implanted"}
• {"criterion_text":"- Age<18years"}
• {"criterion_text":"- Patient under guardianship"}
• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- Prasugrel or ticagrelor use"}

Primary endpoints

• {"endpoint_text":"- Net adverse clinical events: time-to-composite endpoint of bleeding events (BARC2 to BARC 5) and/or ischemic events (all cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) during follow-up (12 months), or time to last follow-up in case of no net adverse clinical event","definition_or_measurement_approach":"Time-to-event analysis of a composite endpoint including bleeding events (BARC 2-5) and/or ischemic events (all-cause death, stroke, stent thrombosis, myocardial infarction, repeat revascularization, rehospitalisation for angina) over 12 months, or time to last follow-up if no event."}

Secondary endpoints

• {"endpoint_text":"- Time-to-bleeding event defined according to BARC classification (BARC 2 to BARC 5) over 12 months follow up, taking into account the competing risk of death from non-haemorrhagic cause, or time to last follow-up in case of no bleeding event","definition_or_measurement_approach":"Time-to-event for bleeding (BARC 2-5) over 12 months, accounting for competing risk of non-haemorrhagic death, or time to last follow-up if no bleeding event."}
• {"endpoint_text":"- Time-to-all cause death over 12 months follow-up, or time to last follow-up in case of no death","definition_or_measurement_approach":"Time-to-event for all-cause death over 12 months, or time to last follow-up if no death."}
• {"endpoint_text":"- Major adverse ischemic clinical events (MACE): time-to-composite endpoint of ischemic stroke, cardiovascular death, stent thrombosis, repeat revascularization, rehospitalisation for angina over 12 months follow-up, taking into account the competing risk of death from non-cardiovascular cause, or time to last follow-up in case of no MACE","definition_or_measurement_approach":"Time-to-event for composite ischemic endpoint (stroke, cardiovascular death, stent thrombosis, repeat revascularization, rehospitalisation for angina) over 12 months, accounting for competing risks, or time to last follow-up if no MACE."}
• {"endpoint_text":"- Compliance to drug regimen at 1-, 6- and 12-months follow-up","definition_or_measurement_approach":"Assessment of treatment adherence/compliance at 1, 6 and 12 months (method not detailed in provided data)."}
• {"endpoint_text":"- Total costs in each treatment group over the one-year study period","definition_or_measurement_approach":"Health economic measurement of total costs per treatment group over 1 year (methodology not specified in provided data)."}
• {"endpoint_text":"- Total quality-adjusted life years in each treatment group over the one-year study period","definition_or_measurement_approach":"Calculation of QALYs per treatment group over 1 year (specific instruments/methods not specified in provided data)."}
• {"endpoint_text":"- Long-term cost-utility ratio (expressed in terms of additional costs per quality adjusted life year gained)","definition_or_measurement_approach":"Cost-utility analysis expressed as incremental cost per QALY gained over a long-term horizon (specific modelling methods not provided)."}

France

Earliest CTIS Part Ii Submission Date

20-03-2024

Latest Decision Or Authorization Date

15-04-2025

Processing Time Days

391

Number Of Sites

11

Number Of Participants

660

Primary sponsor

Full Name

Assistance Publique Hopitaux De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"Ministere de la Sante _DGOS","duties_or_roles":"Source of monetary support","organisation_type":"Government"}