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Acute Myocardial Infarction (AMI)Phase 4MUST ⅡNCT07153744

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

A Phase 4 study testing Aspirin and Shexiang Baoxin Pill in people with Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI), run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aspirin and Shexiang Baoxin Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,588 participants
Where
1 siteChina
Study dates
1 Sep 2025to 31 Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fang Wang, of Medicine (M.Med.) contact

+86 13818403261

wangfang@shpl.com.cn

China1 site
  • Zhongshan Hospital, Fudan University

    Shanghai, 200032

    Hongbo Yang, doctorate in medicine, +86 13585890793, yang.hongbo@zs-hospital.sh.cn

    Jing min Zhou, doctorate in medicine

Other trials in China

About this study

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

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.

Being tested
Aspirin, Shexiang Baoxin Pill
Keywords
Acute Myocardial Infarction, AMI, Percutaneous Coronary Intervention, PCI, Shexiang Baoxin Pill, MUSKARDIA, Shexiang Baoxin Pill(MUSKARDIA), SBP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called standard guideline-directed therapy, ABCDE, Antiplatelet, Beta-blocker

    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 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.

Study groups in NCT07153744
Study groupRoleWhat they receive
the Shexiang Baoxin Pill GroupExperimentalPatients 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.
Receives: Drug: Shexiang Baoxin Pill
the Conventional Treatment GroupActive comparatorPatients in the conventional treatment group will receive standard treatment in accordance with guidelines and consensuses after surgery, and this will last for 12 months.
Receives: Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year after PCI

Secondary outcomes (9)
  1. Incidence of non-fatal myocardial infarction

    Measured: 1 year after PCI

  2. Incidence of non-fatal stroke

    Measured: 1 year after PCI

  3. Rehospitalization rate due to angina pectoris

    Measured: 1 year after PCI

  4. Rate of unplanned revascularization

    Measured: 1 year after PCI

  5. Cardiac mortality rate

    Measured: 1 year after PCI

  6. Rehospitalization rate due to heart failure

    Measured: 1 year after PCI

  7. All-cause mortality rate

    All-cause mortality rate: including cardiac and non-cardiac deaths

    Measured: 1 year after PCI

  8. Seattle Angina Questionnaire score

    Measured: 1 year after PCI

  9. EQ-5D-5L scale

    Measured: 1 year after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
9,588 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153744
Sponsor's protocol ID
HMPE202501
Acronym
MUST Ⅱ
Status last verified
Aug 2025
First submitted
26 Aug 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin and Shexiang Baoxin Pill in people with Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI), run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fang Wang, of Medicine (M.Med.) (+86 13818403261, wangfang@shpl.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of major adverse cardiovascular and cerebrovascular events (MACE) (time frame: 1 year after PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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