NCT07153744

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-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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,588

participants targeted

Target at P75+ for phase_4

Timeline
45mo left

Started Sep 2025

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Sep 2025Dec 2029

First Submitted

Initial submission to the registry

August 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

August 26, 2025

Last Update Submit

August 26, 2025

Conditions

Acute Myocardial Infarction (AMI)Percutaneous Coronary Intervention (PCI)

Keywords

Acute Myocardial InfarctionAMIPercutaneous Coronary InterventionPCIShexiang Baoxin PillMUSKARDIAShexiang Baoxin Pill(MUSKARDIA)SBP

Outcome Measures

Primary Outcomes (1)

  • Incidence of major adverse cardiovascular and cerebrovascular events (MACE)

    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.

    1 year after PCI

Secondary Outcomes (9)

  • Incidence of non-fatal myocardial infarction

    1 year after PCI

  • Incidence of non-fatal stroke

    1 year after PCI

  • Rehospitalization rate due to angina pectoris

    1 year after PCI

  • Rate of unplanned revascularization

    1 year after PCI

  • Cardiac mortality rate

    1 year after PCI

  • +4 more secondary outcomes

Study Arms (2)

the Shexiang Baoxin Pill Group

EXPERIMENTAL

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.

Drug: Shexiang Baoxin Pill

the Conventional Treatment Group

ACTIVE COMPARATOR

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.

Drug: Aspirin

Interventions

AspirinDRUG

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.

Also known as: standard guideline-directed therapy, ABCDE, Antiplatelet, Beta-blocker, Cholesterol, Diet & Diabetes, Education & Exercise
the Conventional Treatment Group
Shexiang Baoxin PillDRUG

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.

the Shexiang Baoxin Pill Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

Location

Related Links

MeSH Terms

Interventions

AspirinAdrenergic beta-AntagonistsCholesterolDietEducational StatusExerciseshexiang baoxin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAdrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsMembrane LipidsLipidsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaSocioeconomic FactorsPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Fang Wang, of Medicine (M.Med.)

CONTACT

+86 13818403261wangfang@shpl.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stratified block randomization by center was performed using a computer-generated random sequence to allocate patients to the Shexiang Baoxin Pill group and the conventional treatment group at a ratio of 2:1. 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. 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 4, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations

CN(1)