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

NCT ID: NCT07153744

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

9588 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the Shexiang Baoxin Pill Group

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.

Group Type EXPERIMENTAL

Shexiang Baoxin Pill

Intervention Type 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.

the Conventional Treatment Group

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.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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standard guideline-directed therapy ABCDE Antiplatelet Beta-blocker Cholesterol Diet & Diabetes Education & Exercise

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai East Hospital

OTHER

Sponsor Role collaborator

Longhua Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Affiliated Hospital of Jiangsu University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

The First People's Hospital of Lianyungang

OTHER

Sponsor Role collaborator

Huai'an First People's Hospital

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Weihai Municipal Hospital

OTHER

Sponsor Role collaborator

Weifang People's Hospital

OTHER

Sponsor Role collaborator

Rizhao People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Jining First People's Hospital

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Yueyang Central Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of University of South China

OTHER

Sponsor Role collaborator

The Central Hospital of Shaoyang

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Changde City

OTHER

Sponsor Role collaborator

Wuxi People's Hospital

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

ZhuZhou Central Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Chenzhou

OTHER

Sponsor Role collaborator

People's Hospital of Quzhou

OTHER

Sponsor Role collaborator

Xuzhou New Health Hospital

UNKNOWN

Sponsor Role collaborator

Taizhou Enze Medical Center Group

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Civil Aviation General Hospital

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Beijing Electric Power Hospital

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Wuhan No.1 Hospital

OTHER

Sponsor Role collaborator

Jingzhou Central Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Ansteel Group General Hospital

UNKNOWN

Sponsor Role collaborator

General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Huaihe Hospital of Henan University

OTHER

Sponsor Role collaborator

Zhoukou Central Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Henan University of Science and Technology

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Nanyang Medical College

OTHER

Sponsor Role collaborator

Jiaozuo Second People's Hospital

UNKNOWN

Sponsor Role collaborator

Anyang Area Hospital of Puyang City

UNKNOWN

Sponsor Role collaborator

Shijiazhuang People's Hospital

OTHER

Sponsor Role collaborator

Cangzhou Central Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Handan Central Hospital

OTHER

Sponsor Role collaborator

The People's Hospital of Langfang City

UNKNOWN

Sponsor Role collaborator

Xingtai Central Hospital

UNKNOWN

Sponsor Role collaborator

North China University of Science and Technology

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

the First Hospital of Anhui University of Science and Technology

UNKNOWN

Sponsor Role collaborator

Chaohu Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Tongling People's Hospital

OTHER_GOV

Sponsor Role collaborator

Huang Shan People's Hospital

OTHER

Sponsor Role collaborator

Huaibei Miners General Hospital

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Changzhi Medical College

OTHER

Sponsor Role collaborator

LinFen People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanxi Cardiovascular Hospital

OTHER

Sponsor Role collaborator

Dazhou First People's Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role collaborator

Yangchun People's Hospital

UNKNOWN

Sponsor Role collaborator

Shaoguan People's Hospital

UNKNOWN

Sponsor Role collaborator

Guilin People's Hospital

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Ji'an Central People's Hospital

UNKNOWN

Sponsor Role collaborator

Jiangxi Provincial People's Hopital

OTHER

Sponsor Role collaborator

People's Hospital of Chongqing

OTHER

Sponsor Role collaborator

Ankang Central Hospital

OTHER

Sponsor Role collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role collaborator

Tianjin Third Central Hospital

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Hainan Medical University

OTHER

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Jilin Province People's Hospital

UNKNOWN

Sponsor Role collaborator

Inner Mongolia Autonomous Region People's Hospital

UNKNOWN

Sponsor Role collaborator

Yan'an Hospital of Kunming City

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Jizhou District, Tianjin

UNKNOWN

Sponsor Role collaborator

The Southwest Hospital of Army Medical University

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Nanning

UNKNOWN

Sponsor Role collaborator

The People' s Hospital of Jiangmen

UNKNOWN

Sponsor Role collaborator

The second People's Hospital of Guiyang

UNKNOWN

Sponsor Role collaborator

The Third People's Hospital of Chengdu

OTHER

Sponsor Role collaborator

The Tirst People's Hospital of Mianyang

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

The First People's Hospital of Chu Zhou

UNKNOWN

Sponsor Role collaborator

Xuancheng people's hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Hutchison Pharmaceuticals Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Fang Wang, of Medicine (M.Med.)

Role: CONTACT

+86 13818403261

Facility Contacts

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Hongbo Yang, doctorate in medicine

Role: primary

+86 13585890793

Jing min Zhou, doctorate in medicine

Role: backup

Related Links

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https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=7e01c957-3c11-4313-95f7-2b9468af2913

National Universal Health Security Information Platform - Medical Research Registration and Filing Information System

Other Identifiers

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HMPE202501

Identifier Type: -

Identifier Source: org_study_id

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