Status:
ENROLLING_BY_INVITATION
Tongmai Jiangtang Capsule for Cardiovascular Clinical Outcomes in High-Risk Metabolic Syndrome Patients
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborating Sponsors:
TCM hospital of Sichuan Province
Xiyuan Hospital of CACMS
Conditions:
Metabolic Syndrome
Cardiovascular Disease (CKD)
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT06908473
Start Date
April 24 2025
End Date
July 31 2028
Last Update
June 13 2025
Active Locations (1)
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1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510405