Polymer-free sirolimus-coated stent with P2Y12-only single antiplatelet therapy versus conventional dual antiplatelet therapy for STEMI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.