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

NCT ID: NCT07088523

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 4205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-12-31

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).

Detailed Description

This study is a large-scale, real-world, prospective, multi-center, non-randomized controlled clinical trail investigating the efficacy of a TCM therapeutic strategy with Xintong Oral Liquid as the core prescription in preventing major adverse cardiovascular and cerebrovascular events (MACCEs) in patients with Ischemic Cardiovascular Disease (ICD) complicated with Diabetes Mellitus (DM). This TCM therapeutic strategy is derived from the "toxins damaging collaterals" theory in TCM pathogenesis. All enrolled patients will receive standard treatment for ICD and DM based on the recommendations of guidelines. This study will employ natural selection grouping based on shared decision-making between physicians and patients, utilizing an open-label design with blinded endpoint assessment. An independent third-party endpoint adjudication committee will be established to conduct impartial evaluation and determination of all endpoint events. The study objective is to determine the following therapeutic effects of Xintong Oral Liquid as compared with standard treatment in the treatment of patients with ICD ccomplicated with DM: (1) 90-days incidence of the composite endpoints of major adverse cardiac and cerebrovascular events (MACCE), including cardiac death, myocardial re-infarction, emergent coronary revascularization and stroke; severe complications of STEMI (including cardiogenic shock, acute left heart failure, mechanical complications and malignant arrhythmias), in-stent thrombosis and major bleeding (Bleeding Academic Research Consortium [BARC] grade III and V); (2) Individual event of the 90-day primary endpoint; severe STEMI complications within 30-day treatment; target vessel failure (TVF) rate of PCI; MACCEs at 30, 180 and 365 days; follow-up assessments of SAQ-7 and EQ-5D-5L; the rate of readmission for heart failure; diabetic microangiopathy.

Conditions

Diabete Mellitus; Ischemic Cardiovascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xintong TCM + Standard Treatment

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.

Group Type: EXPERIMENTAL

Xintong Oral Liquid (Sequential Phase)

Intervention Type: DRUG

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

Xintong Oral Liquid (Intensive Phase)

Intervention Type: DRUG

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

TCM Syndrome Differentiation Decoction

Intervention Type: DRUG

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

Standard Treatment Only

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.

Group Type: ACTIVE_COMPARATOR

Standard Treatment (Guideline-Based)

Intervention Type: 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.

Interventions

Xintong Oral Liquid (Sequential Phase)

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

Intervention Type: DRUG

Xintong Oral Liquid (Intensive Phase)

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

Intervention Type: DRUG

TCM Syndrome Differentiation Decoction

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

Intervention Type: DRUG

Standard Treatment (Guideline-Based)

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Traditional Chinese Medicine Hospital

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Tao Huang

Role: CONTACT

arteries@163.com

18688898958

Zheng Zhen

Role: CONTACT

devotetcm@163.com

19120517600

Facility Contacts

Tao Huang, doctor

Role: primary

arteries@163.com

18688898958

Zheng Zhen, master

Role: backup

devotetcm@163.com

19120517600

Other Identifiers

2023ZD0505604plus

Identifier Type: -

Identifier Source: org_study_id