About this trial
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).
Eligibility criteria
Qualifiers
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";
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Xintong Oral Liquid (Sequential Phase)
- Xintong Oral Liquid (Intensive Phase)
- TCM Syndrome Differentiation Decoction
- Standard Treatment (Guideline-Based)