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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

3612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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ST-elevation Myocardial Infarction (STEMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aspirin 50mg/d

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

Group Type EXPERIMENTAL

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

Intervention Type 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 100mg/d

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No