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NCT Number: NCT07153744

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

Location contact

Hongbo Yang, doctorate in medicine

CONTACT

[email protected]

+86 13585890793

Jing min Zhou, doctorate in medicine

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

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.

Other names: standard guideline-directed therapy, ABCDE, Antiplatelet, Beta-blocker, Cholesterol, Diet & Diabetes, Education & Exercise

Shexiang Baoxin Pill

Drug

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 outcomes

  1. Incidence of major adverse cardiovascular and cerebrovascular events (MACE)

    Time frame: 1 year after PCI

    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.

Secondary outcomes

  1. Incidence of non-fatal myocardial infarction

    Time frame: 1 year after PCI

  2. Incidence of non-fatal stroke

    Time frame: 1 year after PCI

  3. Rehospitalization rate due to angina pectoris

    Time frame: 1 year after PCI

  4. Rate of unplanned revascularization

    Time frame: 1 year after PCI

  5. Cardiac mortality rate

    Time frame: 1 year after PCI

  6. Rehospitalization rate due to heart failure

    Time frame: 1 year after PCI

  7. All-cause mortality rate

    Time frame: 1 year after PCI

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

  8. Seattle Angina Questionnaire score

    Time frame: 1 year after PCI

  9. EQ-5D-5L scale

    Time frame: 1 year after PCI

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Wang, of Medicine (M.Med.)

CONTACT

[email protected]

+86 13818403261

Sponsors and collaborators

Lead sponsor

Shanghai Hutchison Pharmaceuticals Limited

Industry

Collaborators

  • Affiliated Hospital of Jiangsu University
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Ankang Central Hospital
  • Ansteel Group General Hospital
  • Anyang Area Hospital of Puyang City
  • Beijing Chao Yang Hospital
  • Beijing Electric Power Hospital
  • Beijing Friendship Hospital
  • Cangzhou Central Hospital
  • Changzhi Medical College
  • Chaohu Hospital of Anhui Medical University
  • Civil Aviation General Hospital
  • Dazhou First People's Hospital
  • First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Nanyang Medical College
  • First Affiliated Hospital of Ningbo University
  • First People's Hospital of Chenzhou
  • General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
  • General Hospital of Ningxia Medical University
  • Guilin People's Hospital
  • Handan Central Hospital
  • Huai'an First People's Hospital
  • Huaibei Miners General Hospital
  • Huaihe Hospital of Henan University
  • Huang Shan People's Hospital
  • Huashan Hospital
  • Inner Mongolia Autonomous Region People's Hospital
  • Ji'an Central People's Hospital
  • Jiangxi Provincial People's Hopital
  • Jiaozuo Second People's Hospital
  • Jilin Province People's Hospital
  • Jingzhou Central Hospital
  • Jinhua Central Hospital
  • Jining First People's Hospital
  • Lanzhou University Second Hospital
  • LinFen People's Hospital
  • Linyi People's Hospital
  • Longhua Hospital
  • North China University of Science and Technology
  • Peking University People's Hospital
  • People's Hospital of Chongqing
  • People's Hospital of Quzhou
  • Qianfoshan Hospital
  • Renmin Hospital of Wuhan University
  • Rizhao People's Hospital
  • Second Affiliated Hospital of Soochow University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Second Xiangya Hospital of Central South University
  • Shandong Provincial Hospital
  • Shanghai 10th People's Hospital
  • Shanghai 6th People's Hospital
  • Shanghai East Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Zhongshan Hospital
  • Shanxi Cardiovascular Hospital
  • Shaoguan People's Hospital
  • Shijiazhuang People's Hospital
  • Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
  • Sir Run Run Shaw Hospital
  • Taizhou Enze Medical Center Group
  • The Affiliated Hospital Of Southwest Medical University
  • The Affiliated Hospital of Qingdao University
  • The Central Hospital of Shaoyang
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Dalian Medical University
  • The First Affiliated Hospital of Guangdong Pharmaceutical University
  • The First Affiliated Hospital of Henan University of Science and Technology
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of University of South China
  • The First Affiliated Hospital of Zhengzhou University
  • The First Affiliated Hospital with Nanjing Medical University
  • The First Hospital of Hebei Medical University
  • The First People's Hospital of Changde City
  • The First People's Hospital of Chu Zhou
  • The First People's Hospital of Lianyungang
  • The First People's Hospital of Nanning
  • The People' s Hospital of Jiangmen
  • The People's Hospital of Jizhou District, Tianjin
  • The People's Hospital of Langfang City
  • The Second Affiliated Hospital of Fujian Medical University
  • The Second Affiliated Hospital of Hainan Medical University
  • The Southwest Hospital of Army Medical University
  • The Third Affiliated Hospital of Guangzhou Medical University
  • The Third Affiliated Hospital of Wenzhou Medical University
  • The Third People's Hospital of Chengdu
  • The Tirst People's Hospital of Mianyang
  • The second People's Hospital of Guiyang
  • Tianjin Third Central Hospital
  • Tongling People's Hospital
  • Weifang People's Hospital
  • Weihai Municipal Hospital
  • Wuhan No.1 Hospital
  • Wuxi People's Hospital
  • Xiangya Hospital of Central South University
  • Xiangyang Central Hospital
  • Xingtai Central Hospital
  • Xuancheng People's Hospital
  • Xuanwu Hospital, Beijing
  • Xuzhou New Health Hospital
  • Yan'an Affiliated Hospital of Kunming Medical University
  • Yangchun People's Hospital
  • Yueyang Central Hospital
  • Zhoukou Central Hospital
  • ZhuZhou Central Hospital
  • the First Hospital of Anhui University of Science and Technology

Registry information

Official study 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

Acronym: MUST Ⅱ

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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