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

NCT07080684 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: STELAR_CCS_0725
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  Number of participants experiencing any of the following events within 12 months after the index percutaneous coronary intervention (PCI): * Cardiovascular death - Number of participants with death due to a cardiovascular cause * Non-fatal myocardial infarction - Number of participants with myocardial infarction as defined by the Fourth Universal Definition * Non-fatal disabling stroke - Number of participants with stroke resulting in a modified Rankin Scale (mRS) ≥2 * Target lesion revascularization (TLR) - Number of participants undergoing clinically driven revascularization of the target lesion * Major bleeding - Number of participants experiencing major bleeding events defined as BARC type 3 or 5 * All-cause death - Number of participants who died from any cause

  6 month

Secondary Outcomes (8)

• Cardiovascular Death

  6 month

• All cause death

  6 month

• Myocardial Infarction

  6 month

• Major Bleeding (BARC ≥3)

  6 month

• Disabling Stroke

  6 month

Study Arms (2)

Short DAPT with Ticagrelor 60 mg

EXPERIMENTAL

* 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)

Drug: Ticagrelor 60 mg

Standard DAPT with Clopidogrel

ACTIVE COMPARATOR

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

Drug: clopidogrel 75 mg

Interventions

Ticagrelor 60 mg 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.

Short DAPT with Ticagrelor 60 mg

clopidogrel 75 mg 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.

Standard DAPT with Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Messina: lead

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Rodolfo Caminiti

CONTACT

+393286911102; rodolfocaminiti@msn.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Interventional Cardiologist

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07