Tongmai Jiangtang Capsule for Cardiovascular Clinical Outcomes in High-Risk Metabolic Syndrome Patients

Inclusion Criteria:

• Age: Participants must be aged ≥65 years.

• Participants must meet the diagnostic criteria for metabolic syndrome according tothe 2020 Chinese Type 2 Diabetes Prevention Guidelines, which includes at leastthree of the following criteria:①Central obesity: Waist circumference ≥90 cm formen, ≥85 cm for women.②Hyperglycemia: Fasting blood glucose ≥6.1 mmol/L or 2-hourpost-load glucose ≥7.8 mmol/L, or a confirmed diagnosis of diabetes with ongoingtreatment.③Hypertension: Blood pressure ≥130/85 mmHg or a confirmed diagnosis ofhypertension with ongoing treatment.④Elevated triglycerides (TG): ⑤Fasting TG ≥1.70mmol/L.

Low HDL cholesterol: Fasting HDL-C <1.04 mmol/L.

• Participants must meet the criteria for "Qi-deficiency and Blood Stasis" syndrome,which includes specific symptoms and signs such as fatigue, shortness of breath,stabbing pain, ecchymosis, and a tongue with purple discoloration or petechiae.

• High Cardiovascular Risk: Participants must have at least one of the following:

• History of myocardial infarction.

• History of stroke or transient ischemic attack. ③History of coronary,carotid, or peripheral artery revascularization.

• Coronary, carotid, or lower limb artery stenosis >50%. ⑤Positiveexercise stress test or documented symptomatic coronary heartdisease, or unstable angina with ECG changes.

• Chronic heart failure (NYHA Class II-III). ⑦Chronic kidneydisease (eGFR <60 ml/min/1.73m²).

Exclusion Criteria:

• Secondary Abnormalities: Secondary abnormalities in lipids, blood pressure, or bloodglucose.

• Type 1 Diabetes: Participants with Type 1 diabetes mellitus.

• Special Populations: Pregnant or breastfeeding individuals, or those with a historyof allergy to the study medication.

• Recent Acute Events: Acute coronary or cerebrovascular events within the past 14days.

• Upcoming Revascularization: Planned coronary, carotid, or peripheral arteryrevascularization.

• Severe Heart Failure: Chronic heart failure (NYHA Class IV).

• End-Stage Liver Disease: Participants with end-stage liver disease.

• Solid Organ Transplantation: History of solid organ transplantation or awaitingsolid organ transplantation.

• Malignant Tumors: Participants with a history of malignant tumors.

• Other Serious Conditions: Any other serious medical conditions that may interferewith the study or pose a risk to the participant.