Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI (NCT07164859) | Clinical Trial Compass
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 range
65 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.