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

Not Applicable

Not yet recruiting

• Conditions: Acute Myocardial Infarction (AMI); Percutaneous Coronary Intervention (PCI)
• Interventions: Drug: Shexiang Baoxin Pill; Drug: Aspirin

• Registration Number: NCT07153744
• Lead Sponsor: Shanghai Hutchison Pharmaceuticals Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study Start: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2028-12
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9588

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the Shexiang Baoxin Pill Group	Shexiang Baoxin Pill	Patients in the Shexiang Baoxin Pill group initiated treatment immediately after randomization. They received 2-4 pills of Shexiang Baoxin Pill preoperatively before PCI, followed by a maintenance dose of 2-4 pills orally three times daily (TID) with warm water for 12 months postoperatively, concurrently with standard guideline-directed therapy.
the Conventional Treatment Group	Aspirin	Patients in the conventional treatment group will receive standard treatment in accordance with guidelines and consensuses after surgery, and this will last for 12 months.

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse cardiovascular and cerebrovascular events (MACE)	1 year after PCI	Cumulative incidence of MACE events at 1 year from the start of randomization. MACE events include cardiac death, non-fatal myocardial infarction, non-fatal stroke, re-hospitalization for angina pectoris, and unplanned revascularization.

Secondary Outcome Measures

Name	Time	Method
Incidence of non-fatal myocardial infarction	1 year after PCI
Incidence of non-fatal stroke	1 year after PCI
Rehospitalization rate due to angina pectoris	1 year after PCI
Rate of unplanned revascularization	1 year after PCI
Cardiac mortality rate	1 year after PCI
Rehospitalization rate due to heart failure	1 year after PCI
All-cause mortality rate	1 year after PCI	All-cause mortality rate: including cardiac and non-cardiac deaths
Seattle Angina Questionnaire score	1 year after PCI
EQ-5D-5L scale	1 year after PCI

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China