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Not yet recruiting NCT07153744

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

Phase IV Interventional Acute Myocardial Infarction (AMI) Percutaneous Coronary Intervention (PCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, Shexiang Baoxin Pill.
Who it may be relevant to
Registry conditions: Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Incidence of major adverse cardiovascular and cerebrovascular events (MACE) [Time frame: 1 year after PCI]
Secondary outcome measures (9)
  • Incidence of non-fatal myocardial infarction [Time frame: 1 year after PCI]
  • Incidence of non-fatal stroke [Time frame: 1 year after PCI]
  • Rehospitalization rate due to angina pectoris [Time frame: 1 year after PCI]
  • Rate of unplanned revascularization [Time frame: 1 year after PCI]
  • Cardiac mortality rate [Time frame: 1 year after PCI]
  • Rehospitalization rate due to heart failure [Time frame: 1 year after PCI]
  • All-cause mortality rate [Time frame: 1 year after PCI]
  • Seattle Angina Questionnaire score [Time frame: 1 year after PCI]
  • EQ-5D-5L scale [Time frame: 1 year after PCI]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07153744 · HMPE202501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗