NCT07164859

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

Safety and Efficacy of Very Short Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy in Older Patients Undergoing Percutaneous Coronary Intervention (SOLOPCI)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,700 (estimated)
• Sponsor: Vincent ROULE · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Coronary Artery Disease (CAD)
• Percutaneous Coronary Intervention (PCI)
• Antiplatelet Therapy
• Elderly (People Aged 65 or More)

Interventions

Type	Name	Description
DRUG	short dual antiplatelet therapy (DAPT) duration	patients will receive DAPT for 7 days (after randomization) followed by P2Y12 inhibitor alone
DRUG	Standard DAPT duration	patients will receive DAPT for at least 3 months after randomization or longer and followed by single antiplatelet therapy

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2025-09-10
• Last updated: 2025-10-01

Locations

1 site across 1 country: France