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Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction | Clinical Trials | Clareo Health

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Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction

Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction: A Prospective, Multicenter, Pragmatic Randomized Controlled Real-World Study

NCT07153744•Shanghai Hutchison Pharmaceuticals Limited

View on ClinicalTrials.gov

Summary

This study aims to evaluate the value of Shexiang Baoxin Pill (MUSKARDIA) in patients with acute myocardial infarction (AMI) through a prospective, multicenter, pragmatic randomized controlled real-world study. It seeks to validate its efficacy in reducing cardiovascular event risk during the peri-PCI period, as well as its effects on cardiac function, quality of life , and relevant biomarkers. Through this research, we expect to provide higher-quality evidence for the application of SBP in AMI patients undergoing PCI, thereby further optimizing comprehensive treatment strategies for AMI.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 years or older, regardless of gender
•In accordance with the 2023 ESC Guidelines for the Management of Acute Coronary Syndromes , meeting the diagnostic criteria for acute myocardial infarction, including typical chest pain lasting for ≥20 minutes, electrocardiographic manifestations of ST-segment elevation (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), and serum high-sensitivity troponin (hs-cTn) levels exceeding the 99th percentile of the upper reference limit at least once with dynamic changes
•Presenting for treatment within \<24 hours of symptom onset and scheduled to undergo PCI
•The patient or their guardian has signed the informed consent form

Exclusion Criteria

•Having contraindications to PCI treatment
•Being allergic to Shexiang Baoxin Pills, unable to tolerate them, or having other conditions that prevent completion of the trial drug administration
•Being pregnant, planning to become pregnant, or breastfeeding women
•Having participated in other clinical studies within 3 months
•Being deemed unsuitable for inclusion in this study by the researcher

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Key Dates

Start Date

September 1, 2025

Primary Completion Date

December 1, 2028

Completion Date

December 31, 2029

Last Updated

September 4, 2025

Enrollment

9,588

ESTIMATED participants

Conditions

Acute Myocardial Infarction (AMI)Percutaneous Coronary Intervention (PCI)

Interventions

Aspirin

DRUG

Shexiang Baoxin Pill

DRUG

Contacts

Fang Wang, of Medicine (M.Med.)

CONTACT

+86 13818403261 wangfang@shpl.com.cn

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RECRUITINGPHASE4

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Coronary Arterial Disease (CAD)Percutaneous Coronary Intervention (PCI)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction

Inclusion Criteria

Exclusion Criteria

Fast Discharge After Acute Myocardial Infarction Discharge MI

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