Study protocol for low-dose evaluation of aspirin in patients with ST-elevation myocardial infarction undergoing
Wen Zheng1, Zhao-Ting Gong1, Hai-Yan Qian1
1Center for Coronary Artery Disease, Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Insights
This study investigates low-dose versus standard-dose aspirin in Chinese ST-elevation myocardial infarction (STEMI) patients on dual antiplatelet therapy. Findings aim to optimize aspirin maintenance dose for better efficacy and safety in East Asian populations.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor is standard for ST-elevation myocardial infarction (STEMI).
- Optimal aspirin maintenance dose is debated, especially in East Asian populations with higher bleeding sensitivity.
- Standard DAPT regimens may pose increased bleeding risks in specific ethnic groups.
Purpose of the Study:
- To determine the optimal aspirin maintenance dose in Chinese STEMI patients receiving ticagrelor.
- To evaluate the balance between ischemic events and bleeding risk with different aspirin doses.
- To inform population-specific antithrombotic strategies for acute coronary syndrome.
Main Methods:
- The Low-dose Evaluation of Aspirin (LEAST) trial is a multicenter, randomized, double-blind, placebo-controlled study.
- 3612 Chinese STEMI patients post-percutaneous coronary intervention will be randomized.
- Comparing low-dose (50 mg/d) vs. standard-dose (100 mg/d) aspirin with ticagrelor (90 mg twice daily).
Main Results:
- Primary endpoint: 12-month composite of cardiac death, MI, stroke, or revascularization (non-inferiority).
- Secondary endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (superiority).
- Hierarchical testing ensures bleeding benefits are claimed only if ischemic safety is established.
Conclusions:
- The LEAST trial will provide crucial evidence on aspirin dosing for Chinese STEMI patients.
- Findings may lead to tailored antithrombotic strategies for East Asian populations.
- Results could influence future guideline recommendations for acute coronary syndrome management.
Background:
Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor is standard treatment for ST-elevation myocardial infarction (STEMI). While the optimal ticagrelor dose is established, the ideal aspirin maintenance dose remains debatable, particularly in East Asian populations who demonstrate enhanced bleeding sensitivity with standard antiplatelet regimens compared to Western populations.
Methods:
The Low-dose Evaluation of Aspirin in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention (LEAST) trial is a multicenter, randomized, double-blind, placebo-controlled trial comparing low-dose (50 mg/d) versus standard-dose (100 mg/d) aspirin combined with ticagrelor (90 mg twice daily) in Chinese STEMI patients post-percutaneous coronary intervention. A total of 3612 patients will be enrolled from 34 centers across China using stratified randomization by age and multivessel disease status. The primary endpoint is 12-month composite of cardiac death, non-fatal myocardial infarction, non-fatal stroke, and ischemia-driven target vessel revascularization (non-inferiority testing with 1.5% absolute difference margin). The key secondary endpoint is Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (superiority testing). A hierarchical testing strategy ensures bleeding benefits are only claimed when ischemic safety has been established.
Results:
This trial will provide evidence regarding optimal aspirin maintenance dose in Chinese STEMI patients receiving DAPT with ticagrelor. The findings may support development of population-specific antithrombotic strategies that better balance efficacy and safety in East Asian populations.
Conclusion:
The LEAST trial addresses an important knowledge gap regarding optimal aspirin dosing in Chinese STEMI patients and may influence future guideline recommendations for acute coronary syndrome management in Asian populations.
Trial Registration:
ClinicalTrials.gov (NCT06756945).
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