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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hutchison Pharmaceuticals Limited

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Aspirin
  • Shexiang Baoxin Pill

Treatment groups

9,588 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Hutchison Pharmaceuticals Limited

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Huashan Hospital

Collaborator

Shanghai 10th People's Hospital

Collaborator

Shanghai 6th People's Hospital

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Shanghai East Hospital

Collaborator

Longhua Hospital

Collaborator

Second Affiliated Hospital of Soochow University

Collaborator

Affiliated Hospital of Jiangsu University

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

The First People's Hospital of Lianyungang

Collaborator

Huai'an First People's Hospital

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

First Affiliated Hospital of Ningbo University

Collaborator

Shandong Provincial Hospital

Collaborator

Qianfoshan Hospital

Collaborator

Weihai Municipal Hospital

Collaborator

Weifang People's Hospital

Collaborator

Rizhao People's Hospital

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

Jining First People's Hospital

Collaborator

Linyi People's Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Yueyang Central Hospital

Collaborator

The First Affiliated Hospital of University of South China

Collaborator

The Central Hospital of Shaoyang

Collaborator

The First People's Hospital of Changde City

Collaborator

Wuxi People's Hospital

Collaborator

Jinhua Central Hospital

Collaborator

The Third Affiliated Hospital of Wenzhou Medical University

Collaborator

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

Collaborator

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Collaborator

ZhuZhou Central Hospital

Collaborator

First People's Hospital of Chenzhou

Collaborator

People's Hospital of Quzhou

Collaborator

Xuzhou New Health Hospital

Collaborator

Taizhou Enze Medical Center Group

Collaborator

Beijing Chao Yang Hospital

Collaborator

Civil Aviation General Hospital

Collaborator

Xuanwu Hospital, Beijing

Collaborator

Beijing Friendship Hospital

Collaborator

Peking University People's Hospital

Collaborator

Beijing Electric Power Hospital

Collaborator

Renmin Hospital of Wuhan University

Collaborator

Wuhan No.1 Hospital

Collaborator

Jingzhou Central Hospital

Collaborator

The First Affiliated Hospital of Dalian Medical University

Collaborator

Ansteel Group General Hospital

Collaborator

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

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Huaihe Hospital of Henan University

Collaborator

Zhoukou Central Hospital

Collaborator

The First Affiliated Hospital of Henan University of Science and Technology

Collaborator

First Affiliated Hospital of Nanyang Medical College

Collaborator

Jiaozuo Second People's Hospital

Collaborator

Anyang Area Hospital of Puyang City

Collaborator

Shijiazhuang People's Hospital

Collaborator

Cangzhou Central Hospital

Collaborator

The First Hospital of Hebei Medical University

Collaborator

Handan Central Hospital

Collaborator

The People's Hospital of Langfang City

Collaborator

Xingtai Central Hospital

Collaborator

North China University of Science and Technology

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

the First Hospital of Anhui University of Science and Technology

Collaborator

Chaohu Hospital of Anhui Medical University

Collaborator

Tongling People's Hospital

Collaborator

Huang Shan People's Hospital

Collaborator

Huaibei Miners General Hospital

Collaborator

The Second Affiliated Hospital of Fujian Medical University

Collaborator

Changzhi Medical College

Collaborator

LinFen People's Hospital

Collaborator

Shanxi Cardiovascular Hospital

Collaborator

Dazhou First People's Hospital

Collaborator

The Affiliated Hospital Of Southwest Medical University

Collaborator

The Third Affiliated Hospital of Guangzhou Medical University

Collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

Collaborator

Yangchun People's Hospital

Collaborator

Shaoguan People's Hospital

Collaborator

Guilin People's Hospital

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Ji'an Central People's Hospital

Collaborator

Jiangxi Provincial People's Hopital

Collaborator

People's Hospital of Chongqing

Collaborator

Ankang Central Hospital

Collaborator

Xiangyang Central Hospital

Collaborator

Tianjin Third Central Hospital

Collaborator

General Hospital of Ningxia Medical University

Collaborator

The Second Affiliated Hospital of Hainan Medical University

Collaborator

Lanzhou University Second Hospital

Collaborator

Jilin Province People's Hospital

Collaborator

Inner Mongolia Autonomous Region People's Hospital

Collaborator

Yan'an Affiliated Hospital of Kunming Medical University

Collaborator

The People's Hospital of Jizhou District, Tianjin

Collaborator

The Southwest Hospital of Army Medical University

Collaborator

The First People's Hospital of Nanning

Collaborator

The People' s Hospital of Jiangmen

Collaborator

The second People's Hospital of Guiyang

Collaborator

The Third People's Hospital of Chengdu

Collaborator

The Tirst People's Hospital of Mianyang

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

The First People's Hospital of Chu Zhou

Collaborator

Xuancheng People's Hospital

Collaborator