A Phase 3 interventional study of short dual antiplatelet therapy (DAPT) duration and Standard DAPT duration in Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI) and Antiplatelet Therapy, sponsored by Vincent ROULE. Not yet recruiting at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Vincent ROULE · Phase 3, Interventional, and Treatment
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:
While dual antiplatelet therapy (DAPT) is the cornerstone of medical therapy after percutaneous coronary intervention (PCI), its optimal duration is still under debate. DAPT reduces the incidence of thrombotic events but exposes patients to an increased risk of bleeding strongly associated with mortality. Older age is a known predictor of bleeding risk. In the elderly, the duration of DAPT appears to be the most relevant modifiable risk factor.
Bleeding consequences triggered investigations into a further reduction in DAPT duration with the use of the newer generation drug-eluting stent (DES) but none specifically focused on elderly patients. Single antiplatelet therapy (SAPT) using a P2Y12 inhibitor after a short period of DAPT (between 1 and 3 months) has been recently tested in some studies. A meta-analysis focusing on the elderly subgroups (with cut-offs ranging between 65 and 75 years-old) showed similar rates of major bleeding and the composite ischemic endpoint but with a high level of heterogeneity highlighting the need of specific studies in this particular population. A recent large study, including a large proportion of patients ≥ 75 years and comparing SAPT after 1 month of DAPT to DAPT ≥ 3 months, showed a lower incidence of major bleedings while net adverse clinical events and major adverse cardiac events remain non-inferior. In the presence of strong P2Y12 receptor blockade, aspirin provides little additional inhibition of platelet aggregation and inhibition of hemostatic system activation has been reported to be comparable between P2Y12 inhibitor monotherapy and DAPT in healthy subjects. The low thrombogenicity of new coronary devices, potent platelet inhibition with new P2Y12 inhibitors in monotherapy and the potential life-threatening consequences of bleeding which occur mostly in the weeks following PCI support the idea of very short DAPT after PCI in elderly.
The investigators propose a multi-center randomized study to compare the safety and efficacy of very short versus standard-duration DAPT after PCI with DES in elderly patients. The investigators aim to determine whether short DAPT (for 7 days after randomization) followed by SAPT with P2Y12 inhibitor is non inferior to standard-duration DAPT regarding net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined by Bleeding Academic Research Consortium (BARC) 3 or 5) at 1 year in elderly patients undergoing PCI for acute or chronic coronary syndrome.
The investigators hypothesized that the very short strategy will be non-inferior to the standard-duration strategy. The very short strategy may allow to further reduce bleedings while maintaining the ischemic risk and may consequently become the default strategy.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with Vincent ROULE as lead sponsor.
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Exclusion Criteria:
Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:
Patients assigned to standard DAPT duration will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for at least 3 months after randomization or longer and followed by single antiplatelet therapy (aspirin or P2Y12 inhibitor, at the discretion of the local investigator after PCI)
Drug: Standard DAPT duration
Patients assigned to short DAPT will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for 7 days (after randomization) followed by P2Y12 inhibitor alone (ticagrelor, prasugrel or clopidogrel as indicated) for 12 months
Drug: short dual antiplatelet therapy (DAPT) duration
patients will receive DAPT for 7 days (after randomization) followed by P2Y12 inhibitor alone
patients 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
Time frame: 12 months after randomization
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
Time frame: 12 months
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
Time frame: 12 months
Major cardiovascular and cerebrovascular events
a composite of all-cause death, myocardial infarction and stroke, non inferiority of the experimental arm tested
Time frame: 12 months
Major bleeding (BARC 3 or 5)
Major bleeding (BARC 3 or 5), superiority of the experimental arm tested
Time frame: 12 months
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
Time frame: 12 months
all-cause death
Time frame: 12 months
myocardial infarction
myocardial infarction type 1, 3 or 4b based on the universal definition
Time frame: 12 months
Any stroke
Any stroke rates, defined by NeuroARC types 1.a, .b, .c, .d or 1.a.H or 3.a
Time frame: 12 months
Intracranial bleeding
Intracranial bleeding rates defined by NeuroARC type 1.a.H, 1.b, 1.c hemorrhagic CNS injury
Time frame: 12 months
cardiovascular death
Death of cardiovascular cause (according to ARC-2 definition)
Time frame: 12 months
stent thrombosis
stent thrombosis rates (definite or probable, ARC-2 definition)
Time frame: 12 months
All-cause hospitalization
hospitalization for any cause, lasting ≥ 24h from the admission to the hospital
Time frame: 12 months
Urgent/unplanned symptoms-driven coronary revascularization
Unstable angina leading to coronary revascularization (with percutaneous coronary intervention or coronary artery bypass grafting)
Time frame: 12 months
Plan to share: No
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