Elderly patients ≥ 65 years successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent for acute or chronic coronary syndrome
Conditions
Brief summary
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
Detailed description
1) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) non-inferiority, H02, - 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, - all-cause death, - myocardial infarction type 1, 3 or 4b (type 4b defined according ARC-2 definition), - any stroke, - Intracranial bleeding defined by NeuroARC type 1.a.H, 1.b, 1.c hemorrhagic CNS injury, - cardiovascular death (ARC-2 definition), - stent thrombosis (definite or probable, ARC-2 definition), - All-cause hospitalization, - Urgent/unplanned symptoms-driven coronary revascularization, Evaluation criteria of the study are hemorrhagic or thrombotic safety criteria related to the antiplatelet strategies., 2) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) superiority, H03, 3) Major cardiovascular and cerebrovascular events (a composite of all-cause death, myocardial infarction and stroke) non-inferiority, H04, 4) Major bleeding (BARC 3 or 5) superiority, H05
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) non-inferiority, H02, - 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, - all-cause death, - myocardial infarction type 1, 3 or 4b (type 4b defined according ARC-2 definition), - any stroke, - Intracranial bleeding defined by NeuroARC type 1.a.H, 1.b, 1.c hemorrhagic CNS injury, - cardiovascular death (ARC-2 definition), - stent thrombosis (definite or probable, ARC-2 definition), - All-cause hospitalization, - Urgent/unplanned symptoms-driven coronary revascularization, Evaluation criteria of the study are hemorrhagic or thrombotic safety criteria related to the antiplatelet strategies., 2) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) superiority, H03, 3) Major cardiovascular and cerebrovascular events (a composite of all-cause death, myocardial infarction and stroke) non-inferiority, | — |
Countries
France