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NCT07080684Not 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

Short-Term Dual Antiplatelet Therapy With Early Transition to Low-dose Antiplatelet Monotherapy Using ticagRelor in Chronic Coronary Artery Disease

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
3 Jul 2025
Start date
1 Nov 2026
Primary completion date
31 Dec 2027
Lead sponsor
University of Messina
NCT number
NCT07080684

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 1000
  • From 1 Nov 2026 to the primary completion date, 31 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presentation with acute coronary syndrome (ACS), including STEMI, NSTEMI, or unstable angina within the previous 6 mon-ths.
  • Prior stroke with residual neurological deficit or history of di-sabling stroke (mRS ≥3).

Other illness

  • 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.
  • 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.
  • Life expectancy \<1 year due to non-cardiovascular comorbidi-ties (e.g., cancer, advanced renal failure).

Lab values

  • Known platelet disorder, coagulopathy, or thrombocytopenia (\<100,000/mm³).
  • Severe anemia (hemoglobin \<9 g/dL) not corrected before ran-domization.

Other

  • Planned staged PCI or revascularization procedure within 6 months after index PCI.
  • Pregnancy or breastfeeding, or women of childbearing potential who are not using effective contraception.
  • Participation in another interventional clinical trial that may interfere with the outcomes of this study.
  • Inability or unwillingness to provide informed consent or ad-here to study follow-up.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.