D,L-LYSINE ACETYLSALICYLATE (acetylsalicylic acid) for Chronic coronary syndrome | Acute coronary syndrome

Inclusion criteria

• {"criterion_text":"- Patients ≥ 65 years"}
• {"criterion_text":"- Successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent (final TIMI 3 flow and visually estimated residual diameter stenosis <30%) for acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction and unstable angina) or chronic coronary syndrome (elective PCI). Inclusion is possible after the last PCI procedure in staged procedure."}
• {"criterion_text":"- Randomization must be performed before the discharge from the study site."}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- Social security affiliated"}

Exclusion criteria

• {"criterion_text":"- PCI without drug-eluting stent implantation or with a bioresorbable scaffold"}
• {"criterion_text":"- Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel"}
• {"criterion_text":"- Use of fibrinolytic therapy within 24 hours of PCI"}
• {"criterion_text":"- Severe renal insufficiency (MDRD creatinine clearance < 30 ml/min/m2) and/or dialysis"}
• {"criterion_text":"- Increased bleeding risk (prior hemorrhagic stroke; stroke < 30 days; brain injury<6 months; history of intracranial tumor or intracranial hemorrhage; internal bleeding<6 weeks; active bleeding; anemia (hemoglobin ≤ 8 g/dl) or thrombocytopenia (platelets < 100 000 G/L); major surgery<3 weeks)"}
• {"criterion_text":"- patients with poor quality of the downstream territory with diffuse distal coronary disease"}
• {"criterion_text":"- women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy"}
• {"criterion_text":"- increased thrombotic risk related to the patient (previous stent thrombosis, ≥ 2 previous myocardial infarction, symptomatic peripheral artery disease, chronic systemic inflammatory disease treated with corticoids or immunosuppressive drug) or the procedure (left main treated, ≥3 stents/treated lesions, total length of stents>60mm, bifurcation lesion with stents in each branch, stenting of the last patent vessel)"}
• {"criterion_text":"- Life expectancy less than 1 year"}
• {"criterion_text":"- Participation in another interventional trial"}
• {"criterion_text":"- Patients considered as vulnerable by the investigators because of medical, psychological or social conditions: ▪ Patients with known or discovered severe cognitive impairment ▪ Patients with treated or untreated severe psychological or psychiatric conditions ▪ Patients with uncorrected severe hearing or visual handicap ▪ Patients with addictive alcohol, drug or substance abuse ▪ Patients with protective measures (guardianship, tutorship, curatorship) ▪ Any other condition considered by the investigators as not warranting informed consent"}
• {"criterion_text":"- Planned coronary artery bypass grafting or cardiac surgery"}
• {"criterion_text":"- Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period"}
• {"criterion_text":"- Index PCI for stent thrombosis or chronic total occlusion"}
• {"criterion_text":"- Need for oral anticoagulation therapy"}

Primary endpoints

• {"endpoint_text":"- Net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) non-inferiority at 1 year, H01 BARC=Bleeding Academic Research Consortium","definition_or_measurement_approach":"Composite endpoint of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5 assessed at 1 year (non-inferiority analysis)."}

Secondary endpoints

• {"endpoint_text":"- 1) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) non-inferiority, H02","definition_or_measurement_approach":"Bleeding defined by BARC 2, 3 or 5; non-inferiority comparison between strategies."}
• {"endpoint_text":"- net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) evaluated as superior or not","definition_or_measurement_approach":"Same composite as primary, evaluated for superiority."}
• {"endpoint_text":"- all-cause death","definition_or_measurement_approach":"Death from any cause."}
• {"endpoint_text":"- myocardial infarction type 1, 3 or 4b (type 4b defined according ARC-2 definition)","definition_or_measurement_approach":"Myocardial infarction classified by types 1, 3 or 4b; type 4b defined per ARC-2."}
• {"endpoint_text":"- any stroke","definition_or_measurement_approach":"Any cerebrovascular accident as adjudicated."}
• {"endpoint_text":"- Intracranial bleeding defined by NeuroARC type 1.a.H, 1.b, 1.c hemorrhagic CNS injury","definition_or_measurement_approach":"Intracranial hemorrhagic CNS injury classified per NeuroARC types 1.a.H, 1.b, 1.c."}
• {"endpoint_text":"- cardiovascular death (ARC-2 definition)","definition_or_measurement_approach":"Cardiovascular death adjudicated per ARC-2 definition."}
• {"endpoint_text":"- stent thrombosis (definite or probable, ARC-2 definition)","definition_or_measurement_approach":"Stent thrombosis adjudicated as definite or probable per ARC-2 definition."}
• {"endpoint_text":"- All-cause hospitalization","definition_or_measurement_approach":"Hospital admission for any cause."}
• {"endpoint_text":"- Urgent/unplanned symptoms-driven coronary revascularization","definition_or_measurement_approach":"Unplanned coronary revascularization prompted by symptoms."}
• {"endpoint_text":"- Evaluation criteria of the study are hemorrhagic or thrombotic safety criteria related to the antiplatelet strategies.","definition_or_measurement_approach":"Safety criteria focused on hemorrhagic and thrombotic events related to antiplatelet strategies."}
• {"endpoint_text":"- 2) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) superiority, H03","definition_or_measurement_approach":"Bleeding defined by BARC 2, 3 or 5; tested for superiority."}
• {"endpoint_text":"- 3) Major cardiovascular and cerebrovascular events (a composite of all-cause death, myocardial infarction and stroke) non-inferiority, H04","definition_or_measurement_approach":"Composite of all-cause death, myocardial infarction and stroke assessed for non-inferiority."}
• {"endpoint_text":"- 4) Major bleeding (BARC 3 or 5) superiority, H05","definition_or_measurement_approach":"Major bleeding defined by BARC 3 or 5; tested for superiority."}

France

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

27-03-2025

Processing Time Days

71

Number Of Sites

15

Number Of Participants

1700

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Caen Normandie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France