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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
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.
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
Time frame: 6 month
Cardiovascular Death
death due to myocardial infarction, sudden cardiac death, stroke, heart failure, or other vascular causes, as adjudicated by investigators.
Time frame: 6 month
All cause death
death from any cause, cardiovascular or non-cardiovascular.
Time frame: 6 month
Myocardial Infarction
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.
Time frame: 6 month
Major Bleeding (BARC ≥3)
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).
Time frame: 6 month
Disabling Stroke
New-onset neurologic deficit confirmed by imaging and persisting beyond 24 hours, with a modified Rankin Score (mRS) ≥2.
Time frame: 6 month
Target Lesion Revascularization (TLR)
Repeat revascularization (PCI or CABG) of the originally treated lesion due to restenosis or thrombosis.
Time frame: 6 month
Target Vessel Revascularization (TVR)
Any repeat PCI or CABG of the same vessel previously treated, regardless of lesion location.
Time frame: 6 month
Any Ischemic Event
Composite of MI, ischemic stroke, or TLR.
Time frame: 6 month
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