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

NCT ID: NCT07080684

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-09-30

Brief 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.

Conditions

Chronic Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short DAPT with Ticagrelor 60 mg

• 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)

Group Type: EXPERIMENTAL

Ticagrelor 60 mg

Intervention Type: DRUG

Patients in this arm will receive dual antiplatelet therapy (DAPT) consisting of low-dose ticagrelor (60 mg twice daily) plus aspirin (75-100 mg once daily) for 1 month, followed by ticagrelor 60 mg monotherapy for 5 additional months (total 6 months of therapy).

This strategy aims to reduce ischemic events while minimizing bleeding risk by leveraging the potent antiplatelet effect of ticagrelor at a lower maintenance dose.

Standard DAPT with Clopidogrel

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

Group Type: ACTIVE_COMPARATOR

clopidogrel 75 mg

Intervention Type: DRUG

Patients in the control group will receive standard DAPT consisting of clopidogrel 75 mg once daily plus aspirin 75-100 mg once daily for 6 months.

This represents the current standard of care in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents.

Interventions

Ticagrelor 60 mg

Patients in this arm will receive dual antiplatelet therapy (DAPT) consisting of low-dose ticagrelor (60 mg twice daily) plus aspirin (75-100 mg once daily) for 1 month, followed by ticagrelor 60 mg monotherapy for 5 additional months (total 6 months of therapy).

This strategy aims to reduce ischemic events while minimizing bleeding risk by leveraging the potent antiplatelet effect of ticagrelor at a lower maintenance dose.

Intervention Type: DRUG

clopidogrel 75 mg

Patients in the control group will receive standard DAPT consisting of clopidogrel 75 mg once daily plus aspirin 75-100 mg once daily for 6 months.

This represents the current standard of care in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Caminiti

Principal Investigator, Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rodolfo Caminiti

Role: CONTACT

rodolfocaminiti@msn.com

+393286911102

Other Identifiers

STELAR_CCS_0725

Identifier Type: -

Identifier Source: org_study_id