Low‑dose Ticagrelor‑based Short‑Term DAPT versus Standard Aspirin‑Clopidogrel DAPT in Chronic Coronary Syndrome Patients Undergoing PCI (STELAR)

The primary objective is to assess whether a short dual antiplatelet therapy regimen—consisting of 1 month of aspirin plus ticagrelor 60 mg followed by ticagrelor 60 mg monotherapy—is superior to standard 6‑month aspirin plus clopidogrel therapy in reducing net adverse clinical events (NACE) at 6 months in patients with chronic coronary syndrome undergoing percutaneous coronary intervention.

The trial enrolled adult patients with chronic coronary syndrome undergoing percutaneous coronary intervention, both male and female, who were hemodynamically stable and met an acceptable bleeding risk profile. Inclusion required age ≥ 18 years, successful PCI with implantation of new‑generation drug‑eluting stents or drug‑coated balloon treatment, indication for dual antiplatelet therapy, creatinine clearance ≥ 30 mL/min, and an estimated life expectancy greater than one year. Participants had to be free of contraindications to aspirin, clopidogrel, or ticagrelor and capable of complying with study procedures and follow‑up. The sponsor did not provide the total number of participants.

The STELAR trial is a phase 5, randomized, controlled, low‑intervention study evaluating short‑term dual antiplatelet therapy with aspirin plus ticagrelor 60 mg versus standard‑duration therapy with aspirin plus clopidogrel in adults with chronic coronary syndrome undergoing successful percutaneous coronary intervention. After a screening visit confirming eligibility and obtaining informed consent, participants are randomized 1:1 to receive either one month of aspirin (100 mg) plus ticagrelor 60 mg followed by ticagrelor monotherapy, or six months of aspirin (100 mg) plus clopidogrel 75 mg. Study visits occur at baseline (post‑PCI), at 1 month, 6 months (primary endpoint assessment of net adverse clinical events), and at 12 months (secondary endpoint assessment). Additional safety assessments may be performed as required. Participants remain in the trial for up to 12 months; the primary efficacy evaluation is completed at 6 months. Early termination may occur if a participant experiences a serious adverse reaction, develops a contraindication to the study drugs, withdraws consent, or fails to meet protocol‑required follow‑up. The overall recruitment period is planned from July 2026 to July 2029.

The experimental arm utilizes ticagrelor 60 mg film‑coated tablets (Auretica). The tablets are administered orally at a dose of 60 mg twice daily (total 120 mg per day) for one month in combination with aspirin, followed by continuation of ticagrelor 60 mg twice daily as monotherapy through month six.

The comparator regimen includes aspirin 100 mg gastro‑resistant tablets (CARDIOASPIRIN). Aspirin is taken orally once daily and is administered concomitantly with clopidogrel for the full six‑month dual antiplatelet therapy period.

Clopidogrel 75 mg film‑coated tablets are provided as the second comparator drug. The tablets are administered orally once daily and are combined with aspirin for six months as standard‑duration dual antiplatelet therapy.

All study medications are dispensed in accordance with the protocol schedule, and participant compliance is monitored at each study visit by pill count and review of dosing records.

Efficacy will be evaluated using clinical event endpoints. The primary efficacy parameter is net adverse clinical events, defined as the composite of cardiovascular death, myocardial infarction, clinically relevant bleeding, stroke, and ischemia‑driven target‑vessel revascularization, assessed at 6 months post‑PCI. Secondary efficacy assessments include an ischemic composite (cardiovascular death, myocardial infarction, stroke, stent thrombosis, and ischemia‑driven target‑vessel revascularization), net adverse clinical events at 12 months, each individual component of the primary composite, any bleeding (BARC 1–5), minor bleeding (BARC 1–2), unplanned revascularization of any cause, and all‑cause mortality.

Clinical events will be captured through scheduled follow‑up visits at 6 months and 12 months, with additional routine assessments as per standard post‑PCI care. Events will be identified via patient medical records, investigator reports, and adverse event forms, and will be adjudicated by an independent clinical events committee using established definitions, including the Bleeding Academic Research Consortium (BARC) criteria for bleeding severity. Data will be analyzed using time‑to‑event methods, with hazard ratios and confidence intervals calculated for the primary and secondary composites.