Tongmai Jiangtang Capsule for Cardiovascular Clinical Outcomes in High-Risk Metabolic Syndrome Patients (TORCH-met)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status and phase: Invitation-only; Phase 3

Conditions: Cerebrovascular Disease; Cardiovascular Disease (CKD); Metabolic Syndrome; Qi Deficiency and Blood Stasis

Treatments: Drug: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.; Drug: A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC

Study type: Interventional

Funder types: Other

Identifiers

NCT06908473

ZLiu

Details and patient eligibility

About

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.

Enrollment: 530 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: Participants must be aged ≥65 years.
• Participants must meet the diagnostic criteria for metabolic syndrome according to the 2020 Chinese Type 2 Diabetes Prevention Guidelines, which includes at least three of the following criteria:①Central obesity: Waist circumference ≥90 cm for men, ≥85 cm for women.②Hyperglycemia: Fasting blood glucose ≥6.1 mmol/L or 2-hour post-load glucose ≥7.8 mmol/L, or a confirmed diagnosis of diabetes with ongoing treatment.③Hypertension: Blood pressure ≥130/85 mmHg or a confirmed diagnosis of hypertension with ongoing treatment.④Elevated triglycerides (TG): ⑤Fasting TG ≥1.70 mmol/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%. ⑤Positive exercise stress test or documented symptomatic coronary heart disease, or unstable angina with ECG changes.

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

Exclusion criteria

• Secondary Abnormalities: Secondary abnormalities in lipids, blood pressure, or blood glucose.
• Type 1 Diabetes: Participants with Type 1 diabetes mellitus.
• Special Populations: Pregnant or breastfeeding individuals, or those with a history of allergy to the study medication.
• Recent Acute Events: Acute coronary or cerebrovascular events within the past 14 days.
• Upcoming Revascularization: Planned coronary, carotid, or peripheral artery revascularization.
• 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 awaiting solid organ transplantation.
• Malignant Tumors: Participants with a history of malignant tumors.
• Other Serious Conditions: Any other serious medical conditions that may interfere with the study or pose a risk to the participant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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530 participants in 2 patient groups, including a placebo group

Experimental Group (Tongmai Jiangtang Capsule Group)

Experimental group

Description:

Participants in this Arm will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. Dosage: Three capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm aims to evaluate the efficacy of TJC in reducing cardiovascular and cerebrovascular event risks in patients with metabolic syndrome at high cardiovascular risk (HCR-MS). Participants will adhere to the study protocol, attending regular visits and examinations to assess efficacy and safety.

Treatment:

Drug: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment.

Control Group (Placebo Group)

Placebo Comparator group

Description:

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. Dosage: Three placebo capsules, three times daily (tid), taken orally. Duration: The intervention period is 26 weeks, followed by a 26-week follow-up. Objective: This Arm serves as a control to compare the efficacy of TJC against a placebo. Participants will adhere to the study protocol, attending regular visits and examinations to assess the efficacy and safety of the placebo.

Treatment:

Drug: A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC