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).
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"；
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;
Parallel
Xintong Oral Liquid (Sequential Phase)
DrugXintong Oral Liquid (Lunan Pharmaceutical), 10 mL tid po from week 5 to 52.
Xintong Oral Liquid (Intensive Phase)
DrugXintong Oral Liquid (Lunan Pharmaceutical), 20 mL tid po for 4 weeks.
TCM Syndrome Differentiation Decoction
DrugIndividualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.
Standard Treatment (Guideline-Based)
DrugCombination 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.
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).
30-day Severe STEMI Complications (Killip Class II-IV)
Composite of: 1) Cardiogenic shock (Killip IV); 2) Acute heart failure (Killip II-III); 3) Mechanical complications (e.g., ventricular septal rupture); 4) Malignant arrhythmia (sustained VT/VF). Assessed by adjudication committee.
30-day Severe Bleeding (BARC Type 3 or 5)
Bleeding Academic Research Consortium (BARC) criteria: Type 3 (overt bleeding with hemoglobin drop ≥3 g/dL or transfusion) or Type 5 (fatal bleeding).
365-day Target Vessel Failure (TVF) Rate
Composite of: 1) Cardiac death; 2) Target vessel myocardial infarction; 3) Target vessel revascularization (TVR). Angiographically confirmed by core lab.
Change in LVEF (%) from Baseline to 90 days
Left ventricular ejection fraction measured by echocardiography (Simpson's biplane method).
Rate of Change in eGFR (mL/min/1.73 m²/year)
Estimated glomerular filtration rate (eGFR) calculated using CKD-EPI formula. Annualized rate of change derived from serial measurements at baseline, 6, and 12 months.
Rate of Change in UACR (mg/g/year)
Urine albumin-to-creatinine ratio (UACR) measured from first-morning void samples. Annualized rate of change calculated from baseline, 6, and 12-month data.
12-month Renal Composite Endpoint
Composite of: 1) Sustained ≥50% decline in eGFR from baseline; 2) Sustained eGFR \<15 mL/min/1.73 m²; 3) Initiation of long-term dialysis or renal transplantation.
Change in Tubular Markers (α1-MG, β2-MG, NAG) at 12 Months
Urinary biomarkers of tubular injury: α1-microglobulin (α1-MG), β2-microglobulin (β2-MG), and N-acetyl-β-D-glucosaminidase (NAG). Concentrations measured by immunoturbidimetry (α1-MG, β2-MG) and enzymatic assay (NAG).
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