Not Yet RecruitingPhase 3

Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI

France1,700 participantsStarted 2025-10

Plain-language summary

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

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Social security affiliated Exclusion Criteria: * 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 * Need for oral anticoagulation therapy * Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel * Use of fibrinolytic therapy within 24 hours of PCI * Severe renal insufficiency (MDRD creatinine clearance \< 30 ml/min/m2) and/or dialysis * 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); maj…

What they're measuring

net clinical benefit

Timeframe: 12 months after randomization

Trial details

NCT IDNCT07164859

SponsorVincent ROULE

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-10

Contact for this trial

Vincent ROULE, MD, PhD

+33231063975 roule-v@chu-caen.fr