Clinical trial NCT06908473: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Metabolic Syndrome
Cardiovascular Disease (CKD)
Cerebrovascular Disease
Qi Deficiency and Blood Stasis
Keywords: Metabolic Syndrome
High Cardiovascular and Cerebrovascular Risk Metabolic Syndrome, HCR-MS
Qi-Deficiency and Blood Stasis Syndrome
Tongmai Jiangtang Capsule
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: TCM hospital of Sichuan Province
name: Xiyuan Hospital of CACMS
name: Shanxi Provincial hospital of Chinese Medicine
name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Yinchuan Brain-Heart Simultaneous Treatment Internet Hospital Co., Ltd
First posted: 2025-04-03
Enrollment: 530
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Cardiovascular death
timeFrame: From enrollment to the next 52 weeks
measure: Non-fatal myocardial infarction
timeFrame: From enrollment to the next 52 weeks
measure: Non-fatal stroke
timeFrame: From enrollment to the next 52 weeks
Secondary outcomes:
measure: Composite cardiovascular outcomes
timeFrame: From enrollment to the next 52 weeks
measure: All-cause mortality
timeFrame: From enrollment to the next 52 weeks
measure: Renal and diabetes-related microvascular composite outcomes
timeFrame: From enrollment to the next 52 weeks
measure: blood glucose
timeFrame: From enrollment to the next 52 weeks
measure: lipids
timeFrame: From enrollment to the next 52 weeks
measure: Blood pressure
timeFrame: From enrollment to the next 52 weeks
measure: BMI
timeFrame: From enrollment to the next 52 weeks
measure: waist-to-hip ratio
timeFrame: From enrollment to the next 52 weeks
measure: HOMA-IR
timeFrame: From enrollment to the next 52 weeks
measure: Body fat analysis
timeFrame: From enrollment to the next 52 weeks
measure: Vitamin D levels
timeFrame: From enrollment to the next 52 weeks
measure: Assessment of peripheral vascular status
timeFrame: From enrollment to the next 52 weeks
measure: Cardiac function
timeFrame: From enrollment to the next 52 weeks
measure: Cardiovascular risk indices
timeFrame: From enrollment to the next 52 weeks
measure: Traditional Chinese medicine symptom scores
timeFrame: From enrollment to the next 52 weeks
measure: Quality of life scores.
timeFrame: From enrollment to the next 52 weeks
measure: Omics analysis
timeFrame: From enrollment to the next 52 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
References:
citation: 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.