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

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.

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.