Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Acute Myocardial Infarction, AMI, Percutaneous Coronary Intervention, PCI, Shexiang Baoxin Pill, MUSKARDIA, Shexiang Baoxin Pill(MUSKARDIA), SBP
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.
Interventions
DRUGAspirin
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.
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.
Sponsors
Shanghai Zhongshan Hospital
Huashan Hospital
Shanghai 10th People's Hospital
Shanghai 6th People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai East Hospital
Longhua Hospital
Second Affiliated Hospital of Soochow University
Affiliated Hospital of Jiangsu University
The First Affiliated Hospital with Nanjing Medical University
The First People's Hospital of Lianyungang
Huai'an First People's Hospital
Sir Run Run Shaw Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Ningbo University
Shandong Provincial Hospital
Qianfoshan Hospital
Weihai Municipal Hospital
Weifang People's Hospital
Rizhao People's Hospital
The Affiliated Hospital of Qingdao University
Jining First People's Hospital
Linyi People's Hospital
Xiangya Hospital of Central South University
Second Xiangya Hospital of Central South University
Yueyang Central Hospital
The First Affiliated Hospital of University of South China
The Central Hospital of Shaoyang
The First People's Hospital of Changde City
Wuxi People's Hospital
Jinhua Central Hospital
The Third Affiliated Hospital of Wenzhou Medical University
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
ZhuZhou Central Hospital
First People's Hospital of Chenzhou
People's Hospital of Quzhou
Xuzhou New Health Hospital
Taizhou Enze Medical Center Group
Beijing Chao Yang Hospital
Civil Aviation General Hospital
Xuanwu Hospital, Beijing
Beijing Friendship Hospital
Peking University People's Hospital
Beijing Electric Power Hospital
Renmin Hospital of Wuhan University
Wuhan No.1 Hospital
Jingzhou Central Hospital
The First Affiliated Hospital of Dalian Medical University
Ansteel Group General Hospital
General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
The First Affiliated Hospital of Zhengzhou University
Huaihe Hospital of Henan University
Zhoukou Central Hospital
The First Affiliated Hospital of Henan University of Science and Technology
First Affiliated Hospital of Nanyang Medical College
Jiaozuo Second People's Hospital
Anyang Area Hospital of Puyang City
Shijiazhuang People's Hospital
Cangzhou Central Hospital
The First Hospital of Hebei Medical University
Handan Central Hospital
The People's Hospital of Langfang City
Xingtai Central Hospital
North China University of Science and Technology
The First Affiliated Hospital of Anhui Medical University
the First Hospital of Anhui University of Science and Technology
Chaohu Hospital of Anhui Medical University
Tongling People's Hospital
Huang Shan People's Hospital
Huaibei Miners General Hospital
The Second Affiliated Hospital of Fujian Medical University
Changzhi Medical College
LinFen People's Hospital
Shanxi Cardiovascular Hospital
Dazhou First People's Hospital
The Affiliated Hospital Of Southwest Medical University
The Third Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Yangchun People's Hospital
Shaoguan People's Hospital
Guilin People's Hospital
The First Affiliated Hospital of Nanchang University
Ji'an Central People's Hospital
Jiangxi Provincial People's Hopital
People's Hospital of Chongqing
Ankang Central Hospital
Xiangyang Central Hospital
Tianjin Third Central Hospital
General Hospital of Ningxia Medical University
The Second Affiliated Hospital of Hainan Medical University
Lanzhou University Second Hospital
Jilin Province People's Hospital
Inner Mongolia Autonomous Region People's Hospital
Yan'an Hospital of Kunming City
The People's Hospital of Jizhou District, Tianjin
The Southwest Hospital of Army Medical University
The First People's Hospital of Nanning
The People' s Hospital of Jiangmen
The second People's Hospital of Guiyang
The Third People's Hospital of Chengdu
The Tirst People's Hospital of Mianyang
First Affiliated Hospital of Fujian Medical University
The First People's Hospital of Chu Zhou
Xuancheng people's hospital
Shanghai Hutchison Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse cardiovascular and cerebrovascular events (MACE) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Incidence of non-fatal myocardial infarction | 1 year after PCI | — |
| All-cause mortality rate | 1 year after PCI | All-cause mortality rate: including cardiac and non-cardiac deaths |
| Seattle Angina Questionnaire score | 1 year after PCI | — |
| EQ-5D-5L scale | 1 year after PCI | — |
| Rehospitalization rate due to heart failure | 1 year after PCI | — |
Countries
China
Contacts
Primary ContactFang Wang, of Medicine (M.Med.)
Outcome results
None listed