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

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.

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Key information

Conditions

ST-elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily

Drug

STEMI patients receive aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily

aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily

Drug

STEMI patients receive aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily

Primary outcomes

Primary Endpoint 1 (composite ischemic events for non-inferiority testing)

Time frame: 12 months

Primary Endpoint 1 (composite ischemic events for non-inferiority testing) includes all-cause death, non-fatal myocardial infarction, non-fatal stroke, and urgent/ischemia-driven target vessel revascularization
Primary Endpoint 2 (bleeding events for superiority testing)

Time frame: 12 months

Secondary endpoints at 12 months include individual components of the composite ischemic endpoint, stent thrombosis, and safety endpoints comprising BARC type 2-5 bleeding events, GUSTO mild, moderate, and severe/life-threatening bleeding, and non-CABG-related minimal, minor, and major bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Wen Zheng, doctor

CONTACT

[email protected]

86+18611384411

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Acronym: LEAST

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jan 3, 2025
Registry last updated: Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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