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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Huashan Hospital | OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Shanghai 6th People's Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Shexiang Baoxin Pill Group | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-fatal myocardial infarction | 1 year after PCI | |
| Incidence of non-fatal stroke | 1 year after PCI | |
| Rehospitalization rate due to angina pectoris |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Wang, of Medicine (M.Med.) | Contact | +86 13818403261 | wangfang@shpl.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | 200032 | China |
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| Label | URL |
|---|---|
| National Universal Health Security Information Platform - Medical Research Registration and Filing Information System | View source |
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| OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai East Hospital | OTHER |
| Longhua Hospital | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Affiliated Hospital of Jiangsu University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| The First People's Hospital of Lianyungang | OTHER |
| Huai'an First People's Hospital | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| First Affiliated Hospital of Ningbo University | NETWORK |
| Shandong Provincial Hospital | OTHER_GOV |
| Qianfoshan Hospital | OTHER |
| Weihai Municipal Hospital | OTHER |
| Weifang People's Hospital | OTHER |
| Rizhao People's Hospital | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Jining First People's Hospital | OTHER |
| Linyi People's Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| Yueyang Central Hospital | OTHER |
| The First Affiliated Hospital of University of South China | OTHER |
| The Central Hospital of Shaoyang | UNKNOWN |
| The First People's Hospital of Changde City | OTHER |
| Wuxi People's Hospital | OTHER |
| Jinhua Central Hospital | OTHER |
| The Third Affiliated Hospital of Wenzhou Medical University | OTHER |
| Shuguang Hospital of Shanghai University of Traditional Chinese Medicine | UNKNOWN |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | OTHER |
| ZhuZhou Central Hospital | OTHER |
| First People's Hospital of Chenzhou | OTHER |
| People's Hospital of Quzhou | OTHER |
| Xuzhou New Health Hospital | UNKNOWN |
| Taizhou Enze Medical Center Group | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Civil Aviation General Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Beijing Friendship Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Beijing Electric Power Hospital | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| Wuhan No.1 Hospital | OTHER |
| Jingzhou Central Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Ansteel Group General Hospital | UNKNOWN |
| General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group | UNKNOWN |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Huaihe Hospital of Henan University | OTHER |
| Zhoukou Central Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology | OTHER |
| First Affiliated Hospital of Nanyang Medical College | OTHER |
| Jiaozuo Second People's Hospital | UNKNOWN |
| Anyang Area Hospital of Puyang City | UNKNOWN |
| Shijiazhuang People's Hospital | OTHER |
| Cangzhou Central Hospital | OTHER |
| The First Hospital of Hebei Medical University | OTHER |
| Handan Central Hospital | OTHER |
| The People's Hospital of Langfang City | UNKNOWN |
| Xingtai Central Hospital | UNKNOWN |
| North China University of Science and Technology | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| the First Hospital of Anhui University of Science and Technology | UNKNOWN |
| Chaohu Hospital of Anhui Medical University | OTHER |
| Tongling People's Hospital | OTHER_GOV |
| Huang Shan People's Hospital | OTHER |
| Huaibei Miners General Hospital | UNKNOWN |
| The Second Affiliated Hospital of Fujian Medical University | OTHER |
| Changzhi Medical College | OTHER |
| LinFen People's Hospital | UNKNOWN |
| Shanxi Cardiovascular Hospital | OTHER |
| Dazhou First People's Hospital | UNKNOWN |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
| The Third Affiliated Hospital of Guangzhou Medical University | OTHER |
| The First Affiliated Hospital of Guangdong Pharmaceutical University | OTHER |
| Yangchun People's Hospital | UNKNOWN |
| Shaoguan People's Hospital | UNKNOWN |
| Guilin People's Hospital | UNKNOWN |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Ji'an Central People's Hospital | UNKNOWN |
| Jiangxi Provincial People's Hopital | OTHER |
| People's Hospital of Chongqing | OTHER |
| Ankang Central Hospital | OTHER |
| Xiangyang Central Hospital | OTHER |
| Tianjin Third Central Hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| The Second Affiliated Hospital of Hainan Medical University | OTHER |
| Lanzhou University Second Hospital | OTHER |
| Jilin Province People's Hospital | UNKNOWN |
| Inner Mongolia Autonomous Region People's Hospital | UNKNOWN |
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
| The People's Hospital of Jizhou District, Tianjin | UNKNOWN |
| The Southwest Hospital of Army Medical University | UNKNOWN |
| The First People's Hospital of Nanning | UNKNOWN |
| The People' s Hospital of Jiangmen | UNKNOWN |
| The second People's Hospital of Guiyang | UNKNOWN |
| The Third People's Hospital of Chengdu | OTHER |
| The Tirst People's Hospital of Mianyang | UNKNOWN |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| The First People's Hospital of Chu Zhou | UNKNOWN |
| Xuancheng People's Hospital | OTHER |
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.
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|
|
| 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. |
|
| 1 year after PCI |
| Rate of unplanned revascularization | 1 year after PCI |
| Cardiac mortality rate | 1 year after PCI |
| Rehospitalization rate due to heart failure | 1 year after PCI |
| All-cause mortality rate | All-cause mortality rate: including cardiac and non-cardiac deaths | 1 year after PCI |
| Seattle Angina Questionnaire score | 1 year after PCI |
| EQ-5D-5L scale | 1 year after PCI |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000319 | Adrenergic beta-Antagonists |
| D002784 | Cholesterol |
| D004032 | Diet |
| D004522 | Educational Status |
| D015444 | Exercise |
| C526712 | shexiang baoxin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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