Polymer-free sirolimus-coated stent with P2Y12-only single antiplatelet therapy versus conventional dual antiplatelet therapy for STEMI
ST-segment Elevation Myocardial infArction Treated With a Polymer-free Sirolimus-based nanocarrieR Eluting Stent and a P2Y12 Inhibitor-based Aspirin-free Single Antiplatelet Strategy Versus Conventional Dual AntiPlatelet Therapy
This trial will test whether adults treated with emergency PCI for STEMI can be safely managed with a polymer-free sirolimus-coated stent and P2Y12-only single antiplatelet therapy instead of standard aspirin plus a P2Y12 drug.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 2 sites (Geneva, Canton of Geneva and 1 other locations) |
| Trial ID | NCT05785897 on ClinicalTrials.gov |
What this trial studies
Adults with ST-elevation myocardial infarction who undergo successful primary percutaneous coronary intervention with implantation of an Abluminus NP polymer-free sirolimus-eluting stent are randomized to P2Y12 inhibitor–based single antiplatelet therapy (SAPT) or to conventional dual antiplatelet therapy (DAPT) including aspirin. Eligible patients must have received aspirin plus a P2Y12 inhibitor at STEMI diagnosis or at the time of PCI and have target vessel diameter between 2.25 and 4.0 mm treated with the study stent. The trial follows clinical endpoints related to stent healing, stent-related ischemic events, and bleeding over follow-up to compare safety and effectiveness between the antiplatelet strategies. The design aims to determine whether the polymer-free sirolimus stent permits a simplified antiplatelet regimen in this high-risk population.
Who should consider this trial
Good fit: Adults (≥18 years) with STEMI who receive primary PCI with implantation of an Abluminus NP polymer-free sirolimus stent and who started aspirin plus a P2Y12 inhibitor at diagnosis or at PCI are ideal candidates.
Not a fit: Patients with known allergy to aspirin, P2Y12 inhibitors, or sirolimus, those unable to adhere to antiplatelet therapy, or those not treated with the specified stent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce bleeding complications and simplify post-PCI medication while maintaining protection against stent-related ischemic events.
How similar studies have performed: Previous trials of early aspirin discontinuation with continued P2Y12 monotherapy after PCI have shown reduced bleeding and comparable ischemic outcomes in selected populations, while data specifically combining P2Y12 monotherapy with polymer-free sirolimus stents in STEMI remain limited but are beginning to emerge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Age ≥18 years. * Subjects who have received DAPT consisting of aspirin and any of the commercially available P2Y12 receptor inhibitors (ticagrelor, prasugrel, or clopidogrel) at the time of STEMI diagnosis, or at the very latest at the time of primary PCI. * Subjects with ≥1 acute infarct artery target vessel with ≥1 coronary artery stenosis in a native coronary artery with diameter from 2.25 to 4.0 mm who underwent successful primary PCI, defined as primary PCI with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation, and final residual stenosis \<30% by visual estimation or 20% by quantitative coronary angiography (QCA) \[38\]. * Subject willing to participate and able to understand, read and sign the informed consent form. Exclusion criteria: * Known allergy or intolerance to aspirin, ticagrelor, prasugrel, or sirolimus. * Inability to adhere to DAPT for at least 6 months. * Patient already on DAPT at index presentation due to recent PCI for chronic coronary syndrome (\<6 months) or ACS (\<12 months). * Patient on chronic oral anticoagulation at index presentation. * Patient with mechanical complication of STEMI. * Patient with STEMI due to stent thrombosis. * Planned non-cardiac surgery that cannot be postponed for at least 6 months. * Participation or planned participation in another interventional clinical trial. * Life expectancy \<1 years. * Pregnancy. * Unwillingness or inability (e.g. physical or cognitive) to comply with study procedure, medication adherence and schedule.
Where this trial is running
Geneva, Canton of Geneva and 1 other locations
- Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (Recruiting)
- Zurich University Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Juan F. Iglesias, MD — University Hospital, Geneva
- Study coordinator: Véronique Menoni, Study coordinator
- Email: veronique.menoni@hug.ch
- Phone: +41795530516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.