This is a randomized, open-label, active-controlled, non-inferiority clinical trial (the ASPIRE-LD trial) conducted in China. It aims to compare the efficacy and safety of low-dose aspirin (50 mg once daily) versus standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor, in patients who have successfully undergone percutaneous coronary intervention (PCI) and plan to receive at least 12 months of dual antiplatelet therapy (DAPT).
A total of 2640 eligible patients will be randomly assigned in a 1:1 ratio to receive either 50 mg or 100 mg of enteric-coated aspirin daily, plus a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, prescribed according to routine clinical practice). All participants will be followed for 12 months after randomization.
The primary goal is to verify that 50 mg aspirin is non-inferior to the 100 mg standard dose in preventing major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, non-fatal myocardial infarction, definite/probable stent thrombosis, and ischemic stroke) at 12 months post-PCI. If non-inferiority is confirmed, the study will further test whether 50 mg aspirin reduces clinically relevant bleeding events (BARC type 2, 3, or 5) better than the standard dose.
The study is sponsored by the First Hospital of Jilin University and will be carried out in 10-15 tertiary hospitals across China. Its findings will provide evidence for optimizing aspirin dosing in post-PCI DAPT.
Aged 18 to 85 years at the time of screening
Diagnosed with acute coronary syndrome (ACS) or chronic coronary syndrome (CCS)
Has undergone successful percutaneous coronary intervention (PCI) with stent implantation
Planned to receive at least 12 months of dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor after PCI
Known hypersensitivity or contraindication to aspirin, P2Y12 inhibitors, or related excipients
High bleeding risk: history of intracranial hemorrhage, gastrointestinal bleeding within 6 months, active bleeding diathesis, or coagulopathy
Severe hepatic dysfunction (Child-Pugh class C) or severe renal impairment (eGFR < 30 mL/min/1.73 m²)
Ischemic or hemorrhagic stroke within 3 months before enrollment
Parallel
Aspirin
DrugEnteric-coated aspirin for oral administration, once daily. Two dose levels are studied: 50 mg in the experimental arm and 100 mg in the active comparator arm.
P2Y12 inhibitor
DrugBackground antiplatelet therapy used in both study arms. Either ticagrelor 90 mg orally twice daily or clopidogrel 75 mg orally once daily, prescribed at the treating physician's discretion according to clinical guidelines.
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Composite endpoint including cardiovascular death, non-fatal myocardial infarction, definite or probable stent thrombosis, and ischemic stroke, independently adjudicated by a blinded clinical endpoint committee.
Incidence of Clinically Relevant Bleeding Events
Bleeding events classified by the Bleeding Academic Research Consortium (BARC) criteria, including BARC grade 2, 3 and 5.
Net Adverse Clinical Events (NACE)
Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding.
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