Traditional Chinese Medicine Intervention for Ischemic Cardiovascular Disease Comorbid With Diabetes Mellitus: An Efficacy Comparative Study

NCT07088523 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2023ZD0505604plus
• Study Type: interventional
• Target: 4,205
• Locations: 1 country
• Sites: 1

Brief Summary

The population with comorbid ischemic cardiovascular disease (ICD) and diabetes mellitus (DM) has been growing rapidly, characterized by high mortality rates and frequent vascular event recurrence. DM exacerbates ischemic heart disease incidence and significantly elevates mortality in this comorbid population. Polypharmacy in these patients increases risks of adverse drug interactions and imposes substantial healthcare burdens. The pathological mechanisms of comorbidity demonstrate significant alignment with the TCM. Experimental studies indicate that Xintong Oral Liquid can ameliorate myocardial ischemia through multiple mechanisms to improve vascular endothelial function and microvascular dysfunction. This study aims to investigate the long-term effects of TCM intervention in patients with comorbid ICD and DM within 72 hours of symptom onset, and to evaluate whether the TCM treatment approach-centered on Xintong Oral Liquid within an integrated general treatment and syndrome differentiation framework-demonstrates superiority over control therapy in reducing 90-day major adverse cardiovascular and cerebrovascular events (MACCEs).

Conditions

Diabete Mellitus; Ischemic Cardiovascular Disease

Keywords

Diabete Mellitus; Ischemic cardiovascular disease; real-world; Xintong Oral Liquid

Outcome Measures

Primary Outcomes (1)

• 90-day Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs)

  Composite of: 1) Myocardial re-infarction (Third Universal Definition of MI); 2) Emergent coronary revascularization; 3) Stroke (NIHSS ≥1, imaging-confirmed); 4) Cardiovascular death (adjudicated by endpoint committee).

  90 days

Secondary Outcomes (8)

• 30-day Severe STEMI Complications (Killip Class II-IV)

  30 days

• 30-day Severe Bleeding (BARC Type 3 or 5)

  30 days

• 365-day Target Vessel Failure (TVF) Rate

  365 days

• Change in LVEF (%) from Baseline to 90 days

  Baseline, 90 days

• Change in TyG Index from Baseline to 90 days

  Baseline, 90 days

Other Outcomes (4)

• Rate of Change in eGFR (mL/min/1.73 m²/year)

  Baseline, 6 months, 12 months

• Rate of Change in UACR (mg/g/year)

  Baseline, 6 months, 12 months

• 12-month Renal Composite Endpoint

  12 months

Study Arms (2)

Xintong TCM + Standard Treatment

EXPERIMENTAL

1. Intensive phase: Xintong Oral Liquid 20 mL tid po, 4 weeks. 2. Sequential phase: Xintong Oral Liquid 10 mL tid po, weeks 5-52. 3. TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.

Drug: Xintong Oral Liquid (Sequential Phase); Drug: Xintong Oral Liquid (Intensive Phase); Drug: TCM Syndrome Differentiation Decoction

Standard Treatment Only

ACTIVE COMPARATOR

Guideline-based treatment for AMI with diabetes: aspirin (100 mg/day) + clopidogrel (75 mg/day) + atorvastatin (20 mg/day) + metformin (500 mg bid). Other antiplatelet/antidiabetic drugs may be added per clinician discretion.

Drug: Standard Treatment (Guideline-Based)

Interventions

Xintong Oral Liquid (Sequential Phase) DRUG

Xintong Oral Liquid (Lunan Pharmaceutical), 10 mL tid po from week 5 to 52.

Xintong TCM + Standard Treatment

Xintong Oral Liquid (Intensive Phase) DRUG

Xintong Oral Liquid (Lunan Pharmaceutical), 20 mL tid po for 4 weeks.

Xintong TCM + Standard Treatment

TCM Syndrome Differentiation Decoction DRUG

Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.

Xintong TCM + Standard Treatment

Standard Treatment (Guideline-Based) DRUG

Combination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). \*Doses may be adjusted per local guidelines or patient tolerance.

Standard Treatment Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years;
• Met the diagnostic criteria for myocardial infarction and type 2 diabetes mellitus;
• Within 72 hours of myocardial infarction onset;
• Met the diagnostic criteria of "toxins damaging collaterals"；
• Voluntary participation in the study with consent forms signed.

You may not qualify if:

• Long-term (\>20 min) cardio-pulmonary resuscitation (CPR);
• Critical illness due to STEMI (such as serious cardiogenic shock, uncontrolled acute left heart failure or pulmonary edema, malignant arrhythmias, explicit mechanical complications, etc. );
• Suspected aortic dissection or acute pulmonary embolism;
• Bleeding history in any organ system within 1 month, or presence of active hemorrhage at any part of the body, or known hemorrhagic constitution, or severe coagulation disorder or current usage of anticoagulants;
• Uncontrolled severe diabetic ketoacidosis;
• Serious hepatic dysfunction or serious renal dysfunction ( ALT/AST≥3 ULN or eGFR\<30mL/min/1.73 m2 or equiring dialysis );
• Serious COPD or respiratory failure;
• Severe infection (such as positive blood cultures, septic shock, and septic pneumonia, etc.);
• Neuropsychiatric system diseases or unconscious and unable to cooperate with examination and treatment;
• Malignancies or other conditions with expected survival time\<1 year or unsuitability to participate in this study due to other diseases;
• Allergy to the ingredients of the research drugs;
• Women who are in pregnancy or nursery;
• Participation in clinical trial of other traditional Chinese medicine.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Traditional Chinese Medicine Hospital

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Tao Huang

CONTACT

18688898958; arteries@163.com

Zheng Zhen

CONTACT

19120517600; devotetcm@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 28, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)