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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025001668

Enrollment

Unknown

Registered

2025-09-03

Start date

2025-09-15

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Interventions

Shexiang Baoxin Pill group:Administration of Shexiang Baoxin Pill in combination with conventional therapy.

the conventional treatment group:Patients in the conventional treatment group received standard guideline-directed therapy postoperatively.

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1 Aged 18 years or older, regardless of gender 2 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 3 Presenting for treatment within <24 hours of symptom onset and scheduled to undergo PCI 4 The patient or their guardian has signed the informed consent form\

Exclusion criteria

Exclusion criteria: 1 Having contraindications to PCI treatment 2 Being allergic to Shexiang Baoxin Pills, unable to tolerate them, or having other conditions that prevent completion of the trial drug administration 3 Being pregnant, planning to become pregnant, or breastfeeding women 4 Having participated in other clinical studies within 3 months 5 Being deemed unsuitable for inclusion in this study by the researcher

Design outcomes

Primary

Measure	Time frame
Incidence of major adverse cardiovascular and cerebrovascular events (MACE);	—

Secondary

Measure	Time frame
Incidence of non-fatal myocardial infarction;Incidence of non-fatal stroke;Rehospitalization rate due to angina pectoris;Rate of unplanned revascularization;Cardiac mortality rate;Rehospitalization rate due to heart failure;All-cause mortality rate;Seattle Angina Questionnaire (SAQ) Score;Quality of Life;	—

Countries

China

Contacts

Public ContactJunbo GE

Zhongshan Hospital, Fudan University

jbge@zs-hospital.sh.cn13901977506

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026