A Multicenter, Double-Blind, Randomized Controlled Study on the Impact of Tongmai Jiangtang Capsules on the Risk of Cardiovascular and Cerebrovascular Events in Metabolic Syndrome
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Non-fatal myocardial infarction
研究概览
简要总结
- 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).
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Experimental Group (Tongmai Jiangtang Capsule Group)
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.
干预措施: Participants will receive Tongmai Jiangtang Capsule (TJC) in addition to standard treatment. (Drug)
Control Group (Placebo Group)
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.
干预措施: A placebo capsule that is identical in appearance, size, color, formulation, weight, taste, and smell to TJC (Drug)
结局指标
主要结局
Non-fatal myocardial infarction
时间窗: From enrollment to the next 52 weeks
Including spontaneous, STEMI, NSTEMI, PCI-related, CABG-related, and silent acute myocardial infarction
Non-fatal stroke
时间窗: From enrollment to the next 52 weeks
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.
Cardiovascular death
时间窗: From enrollment to the next 52 weeks
sudden cardiac death or death due to myocardial infarction, heart failure, stroke, or other cardiovascular causes.
次要结局
- Composite cardiovascular outcomes(From enrollment to the next 52 weeks)
- All-cause mortality(From enrollment to the next 52 weeks)
- Renal and diabetes-related microvascular composite outcomes(From enrollment to the next 52 weeks)
- blood glucose(From enrollment to the next 52 weeks)
- lipids(From enrollment to the next 52 weeks)
- Blood pressure(From enrollment to the next 52 weeks)
- BMI(From enrollment to the next 52 weeks)
- waist-to-hip ratio(From enrollment to the next 52 weeks)
- HOMA-IR(From enrollment to the next 52 weeks)
- Body fat analysis(From enrollment to the next 52 weeks)
- Vitamin D levels(From enrollment to the next 52 weeks)
- Assessment of peripheral vascular status(From enrollment to the next 52 weeks)
- Cardiac function(From enrollment to the next 52 weeks)
- Cardiovascular risk indices(From enrollment to the next 52 weeks)
- Traditional Chinese medicine symptom scores(From enrollment to the next 52 weeks)
- Quality of life scores.(From enrollment to the next 52 weeks)
- Omics analysis(From enrollment to the next 52 weeks)
研究者
Zhenjie Liu
Doctor
Guangdong Provincial Hospital of Traditional Chinese Medicine