Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial

Обзор

The study aims to optimize the dual antiplatelet therapy regimen for patients with STEMI after PCI, focusing on addressing the following key technical challenges: establishing an effectiveness evaluation system for a low-dose aspirin (50mg/day) antithrombotic treatment strategy based on ticagrelor, including the formulation of a scientific non-inferiority margin, assessment criteria, and composite endpoint determination standards; constructing a strict risk assessment system for major bleeding events, including bleeding event grading based on BARC standards and a blind evaluation process by an independent endpoint event adjudication committee; and developing a quality control system for multicenter clinical research to ensure patient follow-up compliance and data reliability. By solving the above technical challenges, the study provides evidence-based medical support and technical support for optimizing the antithrombotic treatment regimen for STEMI patients after PCI.

Вмешательства

• Препарат aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily
  STEMI patients receive aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily
• Препарат aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily
  STEMI patients receive aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily

Первичные конечные точки

• Primary Endpoint 1 (composite ischemic events for non-inferiority testing) [Срок оценки: 12 months]
• Primary Endpoint 2 (bleeding events for superiority testing) [Срок оценки: 12 months]

Критерии участия

Критерии включения

STEMI patients with clear diagnosis Has received PCI treatment (at least the culprit's blood vessels have been treated); 18 years old and above, regardless of gender; Received DAPT upon discharge: aspirin+ticagrelor; Signed informed consent form approved by the ethics committee

Критерии исключения

Individuals with atrial fibrillation/DVT/valve surgery requiring anticoagulant medication; Combined cardiomyopathy (HCM/DCM/RCM); Combining severe ventricular arrhythmias requires ICD; Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease); Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients; Diseases of the blood system, such as thrombocytopenia, severe anemia, leukemia, etc; Severe liver and kidney dysfunction; Malignant tumors; Cognitive impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Zheng W, Gong ZT, Qian HY. Study protocol for low-dose evaluation of aspirin in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention (LEAST): a multicenter, double-blind, randomized controlled clinical trial. Ann Med. 2025 Dec;57(1):2589577. doi: 10.1080/07853890.2025.2589577. Epub 2025 Nov 23. PMID 41277137

Идентификаторы

NCT: NCT06756945 · 2024AZB1004 · 2024AZB1004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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