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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Cardiovascular death [Time frame: From enrollment to the next 52 weeks]
• Non-fatal myocardial infarction [Time frame: From enrollment to the next 52 weeks]
• Non-fatal stroke [Time frame: From enrollment to the next 52 weeks]

Secondary outcome measures (12)

• Composite cardiovascular outcomes [Time frame: From enrollment to the next 52 weeks]
• All-cause mortality [Time frame: From enrollment to the next 52 weeks]
• Renal and diabetes-related microvascular composite outcomes [Time frame: From enrollment to the next 52 weeks]
• blood glucose [Time frame: From enrollment to the next 52 weeks]
• lipids [Time frame: From enrollment to the next 52 weeks]
• Blood pressure [Time frame: From enrollment to the next 52 weeks]
• BMI [Time frame: From enrollment to the next 52 weeks]
• waist-to-hip ratio [Time frame: From enrollment to the next 52 weeks]
• HOMA-IR [Time frame: From enrollment to the next 52 weeks]
• Body fat analysis [Time frame: From enrollment to the next 52 weeks]
• Vitamin D levels [Time frame: From enrollment to the next 52 weeks]
• Assessment of peripheral vascular status [Time frame: From enrollment to the next 52 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou

Publications

• Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2. PMID 24176437

Identifiers

NCT: NCT06908473 · ZLiu

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗