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Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI (ASPIRE-LD)

2026年9月29日 更新者：Mingyou Zhang、Jilin University

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

Follow-up visits are scheduled at 1 month, 6 months, and 12 months after randomization, including clinical assessment, medication adherence evaluation, and event verification.

研究类型

介入性

注册 (估计的)

2640

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Mingyou 'Zhang', MD
  • 电话号码：+86-13689842200
  • 邮箱：zmy@jlu.edu.cn

学习地点

  • 中国
    • Jilin
      • Changchun、Jilin、中国、130021
        • 招聘中
        • First Hospital of Jilin University
        • 接触：
        • 接触：
          • Mingyou Zhang, MD
          • 电话号码：+86-13689842200
          • 邮箱：zmy@jlu.edu.cn

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Aspirin

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.

其他名称：
  • 乙酰水杨酸
药品：P2Y12 inhibitor

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.

其他名称：
  • 氯吡格雷
  • 替格瑞洛
有源比较器：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.
药品：Aspirin

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.

其他名称：
  • 乙酰水杨酸
药品：P2Y12 inhibitor

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.

其他名称：
  • 氯吡格雷
  • 替格瑞洛

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
大体时间：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.
12 months after randomization

次要结果测量

结果测量
措施说明
大体时间
Incidence of Clinically Relevant Bleeding Events
大体时间：12 months after randomization

Bleeding events classified by the Bleeding Academic Research Consortium (BARC) criteria, including BARC grade 2, 3 and 5.
12 months after randomization
Net Adverse Clinical Events (NACE)
大体时间：12 months after randomization

Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding.
12 months after randomization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jilin University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月1日

初级完成 (估计的)

2029年3月1日

研究完成 (估计的)

2029年4月1日

研究注册日期

首次提交

2026年9月23日

首先提交符合 QC 标准的

2026年9月23日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ASPIRE-LD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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