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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9,588
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.
Zhongshan Hospital, Fudan University
Shanghai, China
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.
Time frame: 1 year after PCI
Incidence of non-fatal myocardial infarction
Time frame: 1 year after PCI
Incidence of non-fatal stroke
Time frame: 1 year after PCI
Rehospitalization rate due to angina pectoris
Time frame: 1 year after PCI
Rate of unplanned revascularization
Time frame: 1 year after PCI
Cardiac mortality rate
Time frame: 1 year after PCI
Rehospitalization rate due to heart failure
Time frame: 1 year after PCI
All-cause mortality rate
All-cause mortality rate: including cardiac and non-cardiac deaths
Time frame: 1 year after PCI
Seattle Angina Questionnaire score
Time frame: 1 year after PCI
EQ-5D-5L scale
Time frame: 1 year after PCI
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