Coronary disease & ACS

Potent P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: Rationale and design of the STARS dual antiplatelet therapy (DAPT) randomized pilot trial

Am Heart JPublished investigator-initiated, prospective, multicenter, open-label, precision-based, randomized controlled pilot trial with a blinded outcome assessment

Study context

Population
Patients with STEMI who underwent successful primary percutaneous coronary intervention (PCI) of the culprit lesion with a newer-generation polymer-free drug-eluting-stent (DES)planned recruitment target ("aims to recruit a total of"), no results reported
Participants
350 patients
Planned comparison
Potent P2Y12 inhibitor-based single antiplatelet therapy (SAPT) vs Standard DAPT
Primary endpoint
Primary efficacy endpoint: Major adverse cardiac and cerebrovascular events (MACCE) (composite of all-cause death, non-fatal myocardial re-infarction, non-fatal stroke, urgent target vessel revascularization, or definite/probable stent thrombosis); primary safety endpoint: Bleeding Academic Research Consortium (BARC) class 3 or 5 major bleeding
Follow-up
12 months
Methodological detailsrandomized in a 1:1 ratio
  • Randomized in a 1:1 ratio

No results yet. This paper sets out the design of a trial; its results are to come.

Further findings

Study conduct

The first patient was enrolled on December 1, 2025.
The study is designed to provide estimates of treatment effects and their precision to inform the design of a subsequent larger randomized trial.

Original publication

Potent P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: Rationale and design of the STARS DAPT randomized pilot trial. Am Heart J. Published 1 November 2026. doi:10.1016/j.ahj.2026.107648

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