An interventional study of Aspirin and P2Y12 inhibitor in Coronary Artery Disease, Acute Coronary Syndromes and Chronic Coronary Syndrome, sponsored by Jilin University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Jilin University · Not applicable, Interventional, and Treatment
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.
Background Dual antiplatelet therapy (DAPT) - aspirin combined with a P2Y12 inhibitor - is the standard of care to prevent stent thrombosis and ischemic events after PCI. However, the optimal aspirin dose in combination with modern P2Y12 inhibitors remains undefined, especially in Chinese populations. Current practice widely uses 100 mg daily aspirin, but pharmacological and clinical evidence suggests that lower doses may achieve comparable antiplatelet effect with a lower bleeding risk.
Study Design This is a multicenter, randomized, open-label, active parallel-controlled non-inferiority trial. Enrollment will include 2640 adults with acute or chronic coronary syndrome who have undergone successful PCI and are scheduled for at least 12 months of DAPT. Randomization will be stratified by study center with a 1:1 allocation ratio.
Treatment Regimens
Outcome Assessment All suspected endpoint events will be independently adjudicated by a blinded Clinical Endpoint Committee according to standardized international definitions. A Data Monitoring Committee will periodically review safety data and study conduct.
Follow-up visits are scheduled at 1 month, 6 months, and 12 months after randomization, including clinical assessment, medication adherence evaluation, and event verification.
Exclusion Criteria:
Participants receive enteric-coated aspirin 50 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention.
Drug: Aspirin · Drug: P2Y12 inhibitor
Participants receive enteric-coated aspirin 100 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention.
Drug: Aspirin · Drug: P2Y12 inhibitor
Enteric-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.
Also known as: Acetylsalicylic Acid
Background 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.
Also known as: Ticagrelor, Clopidogrel
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.
Time frame: 12 months after randomization
Incidence of Clinically Relevant Bleeding Events
Bleeding events classified by the Bleeding Academic Research Consortium (BARC) criteria, including BARC grade 2, 3 and 5.
Time frame: 12 months after randomization
Net Adverse Clinical Events (NACE)
Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding.
Time frame: 12 months after randomization
Plan to share: No — Individual participant data will not be shared to protect patient privacy and confidentiality. This is an investigator-initiated trial without dedicated funding and specialized resources for public data sharing. Aggregate results of the study will be published in peer-reviewed academic journals.
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Jilin University