Chronic Coronary Syndrome
Conditions
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.
Interventions
DRUGTicagrelor 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.
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.
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of cardiovascular death, myocardial infarction, disabling stroke, target lesion revascularization, major bleeding, and all-cause death | 6 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | 6 month | death from any cause, cardiovascular or non-cardiovascular. |
| Myocardial Infarction | 6 month | Defined according to ARC-2 criteria as either spontaneous (type 1), peri-procedural (type 4a/4b), or stent thrombosis-related, confirmed by clinical symp-toms, ECG changes, and biomarker elevation. |
| Major Bleeding (BARC ≥3) | 6 month | Bleeding events classified as Bleeding Academic Research Consortium (BARC) type 3a (overt bleeding with hemoglobin drop ≥3 g/dL), 3b (requiring in-tervention or surgery), 3c (intracranial or intraocular), or type 5 (fatal bleeding). |
| Cardiovascular Death | 6 month | death due to myocardial infarction, sudden cardiac death, stroke, heart failure, or other vascular causes, as adjudicated by investigators. |
| Target Lesion Revascularization (TLR) | 6 month | Repeat revascularization (PCI or CABG) of the originally treated lesion due to restenosis or thrombosis. |
| Target Vessel Revascularization (TVR) | 6 month | Any repeat PCI or CABG of the same vessel previously treated, regardless of lesion location. |
| Any Ischemic Event | 6 month | Composite of MI, ischemic stroke, or TLR. |
| Disabling Stroke | 6 month | New-onset neurologic deficit confirmed by imaging and persisting beyond 24 hours, with a modified Rankin Score (mRS) ≥2. |
Contacts
Primary ContactRodolfo Caminiti
Outcome results
None listed