Not Yet RecruitingPhase 4

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

1,000 participantsStarted 2025-12-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 limi…

What they're measuring

Composite of cardiovascular death, myocardial infarction, disabling stroke, target lesion revascularization, major bleeding, and all-cause death

Timeframe: 6 month

Trial details

NCT IDNCT07080684

SponsorUniversity of Messina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Rodolfo Caminiti

+393286911102 rodolfocaminiti@msn.com