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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Messina

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ticagrelor 60 mg
  • clopidogrel 75 mg

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators