About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- short dual antiplatelet therapy (DAPT) duration
- Standard DAPT duration
Treatment groups
Sponsors and collaborators
Vincent ROULE
Lead sponsor
University Hospital, Caen
Sponsor institution