1. Conduct a large-sample, multicenter, superiority, double-blind, randomized controlled clinical trial to verify the efficacy of TJC in reducing the risk of cardiovascular and cerebrovascular events in patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS). 2. Further construct an evaluation system for the long-term cardiovascular and cerebrovascular benefits of traditional Chinese medicine in regulating glucose and lipid metabolism through the evaluative study of the cardiovascular and cerebrovascular benefits of TJC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
530
Intervention Agent: The study employs Tongmai Jiangtang Capsule (TJC), a traditional Chinese medicine compound formulated based on TCM theory. It has the functions of Nourishing Yin, clearing heat and activating blood circulation, and can comprehensively regulate glucose and lipid metabolism as well as improve cardiovascular and cerebrovascular functions. Intervention Population: The study focuses on patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS) who meet the TCM criteria for "Qi-deficiency and Blood Stasis syndrome," reflecting personalized and precision intervention. Intervention Design: A long-term study design with 26 weeks of intervention followed by 26 weeks of follow-up is adopted to comprehensively assess the short-term efficacy and long-term cardiovascular benefits of TJC. Control Design: The study employs a double-blind, randomized, placebo-controlled method.
Participants in this Arm will receive a placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC, in addition to standard treatment.
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Cardiovascular death
sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes.
Time frame: From enrollment to the next 52 weeks
Non-fatal myocardial infarction
Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction
Time frame: From enrollment to the next 52 weeks
Non-fatal stroke
Meet any one of the following criteria: * Acute neurological dysfunction documented by CT/MRI, attributable to vascular causes with other etiologies excluded; ② Transient ischemic attack (TIA) lasting \<24 hours; ③ Microhemorrhage: Round hypointense lesions \<5-10 mm on MRI.
Time frame: From enrollment to the next 52 weeks
Composite cardiovascular outcomes
death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina or heart failure
Time frame: From enrollment to the next 52 weeks
All-cause mortality
Any cause of death
Time frame: From enrollment to the next 52 weeks
Renal and diabetes-related microvascular composite outcomes
Including renal outcomes or diabetic retinopathy outcomes
Time frame: From enrollment to the next 52 weeks
blood glucose
Including fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2h PPG), and glycated hemoglobin (HbA1c).
Time frame: From enrollment to the next 52 weeks
lipids
Including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Time frame: From enrollment to the next 52 weeks
Blood pressure
Including systolic blood pressure and systolic blood pressure
Time frame: From enrollment to the next 52 weeks
BMI
Body Mass Index
Time frame: From enrollment to the next 52 weeks
waist-to-hip ratio
waist-to-hip ratio
Time frame: From enrollment to the next 52 weeks
HOMA-IR
HOMA-IR=(Fasting Glucose (mmol/L)×Fasting Insulin (μU/mL))/22.5
Time frame: From enrollment to the next 52 weeks
Body fat analysis
Including Body Fat Percentage (BFP) and Visceral Fat Index (VFI)
Time frame: From enrollment to the next 52 weeks
Vitamin D levels
Vitamin D levels
Time frame: From enrollment to the next 52 weeks
Assessment of peripheral vascular status
Assessment of plaque or stenosis in the common carotid artery
Time frame: From enrollment to the next 52 weeks
Cardiac function
Including Cardiac Enzymes, Troponin, BNP, Ejection Fraction (EF), Left Ventricular Myocardial Thickness, and Interventricular Septal Thickness.
Time frame: From enrollment to the next 52 weeks
Cardiovascular risk indices
Including the China-PAR Score, Framingham Risk Score, and QRISK3 Score.
Time frame: From enrollment to the next 52 weeks
Traditional Chinese medicine symptom scores
Including symptoms related to observation, hearing, questioning, and palpation.
Time frame: From enrollment to the next 52 weeks
Quality of life scores.
The Short-From-36 Health Survey, SF-36
Time frame: From enrollment to the next 52 weeks
Omics analysis
Including transcriptomics, proteomics, untargeted metabolomics, and microbiome analysis.
Time frame: From enrollment to the next 52 weeks
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