The goal of this clinical trial is to learn if reducing the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (short treatment regimen, stopping aspirin at day 7) is as safe and efficient as the standard DAPT duration (standard treatment regimen) in elderly patients ≥ 65 years.
The main questions it aims to answer are:
Does the reduction of the duration of DAPT reduces rates of bleeding without increasing the risk of cardiovascular events? Researchers will compare a short treatment by DAPT (7 days, followed by single antiplatelet therapy) to a standard treatment duration by DAPT (3 to 12 months) after successful percutaneous coronary intervention with ≥ 1 drug-eluting stent.
Participants will:
* Take aspirin for 7 days in one group or 3 to 12 months in another group * Be contacted by phone at 7 days, 14 days, 21 days, 30 days, 3 months, 6 months and 12 months after hospital discharge * Keep a diary of any bleeding or cardiovascular events occurring during the study period
Patients ≥ 65 years
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.
Randomization must be performed before the discharge from the study site.
Written informed consent
PCI without drug-eluting stent implantation or with a bioresorbable scaffold
Planned coronary artery bypass grafting or cardiac surgery
Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period
Index PCI for stent thrombosis or chronic total occlusion
Parallel
short dual antiplatelet therapy (DAPT) duration
Drugpatients will receive DAPT for 7 days (after randomization) followed by P2Y12 inhibitor alone
Standard DAPT duration
Drugpatients will receive DAPT for at least 3 months after randomization or longer and followed by single antiplatelet therapy
net clinical benefit
composite of all-cause death, myocardial infarction, stroke and major bleeding BARC 3 or 5
Major or clinically relevant non-major bleeding
Major or clinically relevant non-major bleeding (BARC 2, 3 or 5), non inferiority of the experimental arm tested
Major or clinically relevant non-major bleeding
Major or clinically relevant non-major bleeding (BARC 2, 3 or 5), superiority of the experimental arm tested
Major cardiovascular and cerebrovascular events
a composite of all-cause death, myocardial infarction and stroke, non inferiority of the experimental arm tested
Major bleeding (BARC 3 or 5)
Major bleeding (BARC 3 or 5), superiority of the experimental arm tested
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
myocardial infarction type 1, 3 or 4b based on the universal definition
Any stroke
Any stroke rates, defined by NeuroARC types 1.a, .b, .c, .d or 1.a.H or 3.a
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Vincent ROULE
Lead sponsor
University Hospital, Caen
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
