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

HUTCHMED

Status and phase: Not yet enrolling; Phase 4

Conditions: Acute Myocardial Infarction (AMI); Percutaneous Coronary Intervention (PCI)

Treatments: Drug: Shexiang Baoxin Pill; Drug: Aspirin

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT07153744

HMPE202501

Details and patient eligibility

About

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.

Enrollment: 9,588 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,588 participants in 2 patient groups

the Shexiang Baoxin Pill Group

Experimental group

Description:

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.

Treatment:

Drug: Shexiang Baoxin Pill

the Conventional Treatment Group

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin