Aspirin: Patients in the Shexiang Baoxin Pill(MUSKARDI) 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.
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital, Fudan University
Shanghai
China
More Shanghai Hutchison Pharmaceuticals Limited trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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