Short-Term Dual Antiplatelet Therapy With Early Transi-tion to Low-dose Antiplatelet Monotherapy Using Ti-cagRelor in Chronic Coronary Artery Disease (STELAR)

University of Messina

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Coronary Syndrome

Treatments: Drug: clopidogrel 75 mg; Drug: Ticagrelor 60 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07080684

STELAR_CCS_0725

Details and patient eligibility

About

This is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication (PROBE design), comparing one-month dual antiplatelet therapy (DAPT) with low-dose ticagrelor (60 mg BID) followed by ticagrelor monotherapy to standard 6-month DAPT with aspirin and clopidogrel in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI). The primary endpoint is a composite of cardiovascular death, all-cause death, myocardial infarction, disabling stroke, target lesion revascularization (TLR), and major bleeding. The study aims to evaluate whether the short DAPT strategy reduces ischemic events while maintaining bleeding safety.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years at the time of informed consent.
• Diagnosis of chronic coronary syndrome (CCS) according to ESC guidelines.
• Undergoing successful PCI with implantation of one or more new-generation drug-eluting stents (DES).
• Indication for dual antiplatelet therapy (DAPT) following PCI.
• Willingness and ability to comply with all study procedures and follow-up assessments.
• Signed informed consent prior to any study-specific procedure.
• Creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
• Life expectancy greater than 1 year in the investigator's judg-ment.
• Hemodynamically stable at the time of randomization.
• Acceptable bleeding risk profile: patients fulfilling ARC-HBR criteria may be included only if the treating physician deems a 6-month antiplatelet regimen to be safe.
• No contraindications to study drugs, including aspirin, clopi-dogrel, or ticagrelor.

Exclusion criteria

• Presentation with acute coronary syndrome (ACS), including STEMI, NSTEMI, or unstable angina within the previous 6 mon-ths.
• Planned staged PCI or revascularization procedure within 6 months after index PCI.
• Requirement for long-term oral anticoagulation therapy, such as for atrial fibrillation, mechanical heart valves, or venous thromboembolism.
• History of major bleeding, including gastrointestinal or intra-cranial bleeding, within the past 6 months.
• Severe hepatic impairment, active liver disease, or transamina-ses >3× upper limit of normal.
• Known platelet disorder, coagulopathy, or thrombocytopenia (<100,000/mm³).
• Contraindication or hypersensitivity to aspirin, clopidogrel, or ticagrelor, or known drug interaction that precludes their use.
• Ongoing active bleeding or high risk of bleeding that, in the opinion of the investigator, precludes DAPT.
• Pregnancy or breastfeeding, or women of childbearing potential who are not using effective contraception.
• Life expectancy <1 year due to non-cardiovascular comorbidi-ties (e.g., cancer, advanced renal failure).
• Participation in another interventional clinical trial that may interfere with the outcomes of this study.
• Severe anemia (hemoglobin <9 g/dL) not corrected before ran-domization.
• Inability or unwillingness to provide informed consent or ad-here to study follow-up.
• Prior stroke with residual neurological deficit or history of di-sabling stroke (mRS ≥3).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Short DAPT with Ticagrelor 60 mg

Experimental group

Description:

* 1-month DAPT: aspirin + ticagrelor 60 mg BID * Followed by 5-month ticagrelor 60 mg BID monotherapy * Ticagrelor will be provided by the sponsor (off-label use)

Treatment:

Drug: Ticagrelor 60 mg

Standard DAPT with Clopidogrel

Active Comparator group

Description:

- 6-month DAPT: aspirin + clopidogrel 75 mg daily

Treatment:

Drug: clopidogrel 75 mg