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Safety and efficacy of very short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy in older patients undergoing percutaneous coronary intervention.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507545-28-00
Acronym
23-0165
Enrollment
1700
Registered
2025-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients ≥ 65 years successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent for acute or chronic coronary syndrome

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

Centre Hospitalier Universitaire De Caen Normandie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026