Traditional Chinese Medicine Intervention for Ischemic Cardiovascular Disease Comorbid With Diabetes Mellitus: An Efficacy Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 4,205
- 试验地点
- 1
- 主要终点
- 90-day Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Xintong TCM + Standard Treatment
- Intensive phase: Xintong Oral Liquid 20 mL tid po, 4 weeks.
- Sequential phase: Xintong Oral Liquid 10 mL tid po, weeks 5-52.
- TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.
干预措施: Xintong Oral Liquid (Sequential Phase) (Drug)
Xintong TCM + Standard Treatment
- Intensive phase: Xintong Oral Liquid 20 mL tid po, 4 weeks.
- Sequential phase: Xintong Oral Liquid 10 mL tid po, weeks 5-52.
- TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.
干预措施: Xintong Oral Liquid (Intensive Phase) (Drug)
Xintong TCM + Standard Treatment
- Intensive phase: Xintong Oral Liquid 20 mL tid po, 4 weeks.
- Sequential phase: Xintong Oral Liquid 10 mL tid po, weeks 5-52.
- TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.
干预措施: TCM Syndrome Differentiation Decoction (Drug)
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.
干预措施: Standard Treatment (Guideline-Based) (Drug)
结局指标
主要结局
90-day Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs)
时间窗: 90 days
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).
次要结局
- 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)
- SAQ-7 Angina Frequency Score at baseline, 3, 6, 12 Months(Baseline, 3, 6, 12 Months)
- EQ-5D-5L Utility Score at baseline, 3, 6, 12 Months(Baseline, 3, 6, 12 Months)
- Heart Failure Readmission Rate at 180 Days and 365 Days(180 days, 365 days)