Status:
NOT_YET_RECRUITING
Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction
Lead Sponsor:
Shanghai Hutchison Pharmaceuticals Limited
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Huashan Hospital
Conditions:
Acute Myocardial Infarction (AMI)
Percutaneous Coronary Intervention (PCI)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-wo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
9588 Patients enrolled
Trial Details
Trial ID
NCT07153744
Start Date
September 1 2025
End Date
December 31 2029
Last Update
September 4 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, China, 200032