The Efficacy and Safety of Aspirin 50mg Versus 100mg in Combination With a P2Y12 Inhibitor After Percutaneous Coronary Intervention: A Randomized, Open-label, Active-controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,640
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
研究概览
简要总结
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.
详细描述
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
- Experimental group: enteric-coated aspirin 50 mg once daily + a P2Y12 inhibitor
- Control group: enteric-coated aspirin 100 mg once daily + a P2Y12 inhibitor The choice of P2Y12 inhibitor (ticagrelor or clopidogrel) is at the treating physician's discretion based on patient characteristics and clinical guidelines. DAPT will be maintained for a minimum of 12 months.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Although the trial is open-label for participants and treating clinicians, an independent Clinical Endpoint Committee (CEC) is masked to treatment assignment when adjudicating all endpoint events (ischemic events and bleeding events) to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. 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
- •Able to provide written informed consent and comply with study follow-up requirements
排除标准
- •1. 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
- •Pregnant or lactating women; women of childbearing potential unwilling to use effective contraception
- •Life expectancy < 12 months due to other severe comorbidities such as advanced malignancy
- •Participation in another interventional clinical trial within 30 days before screening
- •Any other condition judged by the investigator to make the patient unsuitable for the study
研究组 & 干预措施
Low-dose Aspirin
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.
干预措施: P2Y12 inhibitor (Drug)
Standard-dose Aspirin
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.
干预措施: P2Y12 inhibitor (Drug)
Standard-dose Aspirin
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.
干预措施: Aspirin (Drug)
Low-dose Aspirin
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.
干预措施: Aspirin (Drug)
结局指标
主要结局
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
时间窗: 12 months after randomization
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.
次要结局
- Incidence of Clinically Relevant Bleeding Events(12 months after randomization)
- Net Adverse Clinical Events (NACE)(12 months after randomization)
研究者
Mingyou Zhang
Associate Chief Physician, Department of Cardiology
Jilin University