[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599748":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":51,"responsibleParty":70,"collaborators":28,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":96,"whyStopped":28,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Guangzhou University of Traditional Chinese Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Xintong TCM + Standard Treatment","EXPERIMENTAL","1. Intensive phase: Xintong Oral Liquid 20 mL tid po, 4 weeks.\n2. Sequential phase: Xintong Oral Liquid 10 mL tid po, weeks 5-52.\n3. TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.",[13,14,15],"Drug: Xintong Oral Liquid (Sequential Phase)","Drug: Xintong Oral Liquid (Intensive Phase)","Drug: TCM Syndrome Differentiation Decoction",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard Treatment Only","ACTIVE_COMPARATOR","Guideline-based treatment for AMI with diabetes: aspirin (100 mg\u002Fday) + clopidogrel (75 mg\u002Fday) + atorvastatin (20 mg\u002Fday) + metformin (500 mg bid). Other antiplatelet\u002Fantidiabetic drugs may be added per clinician discretion.",[21],"Drug: Standard Treatment (Guideline-Based)",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Xintong Oral Liquid (Sequential Phase)","Xintong Oral Liquid (Lunan Pharmaceutical), 10 mL tid po from week 5 to 52.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Xintong Oral Liquid (Intensive Phase)","Xintong Oral Liquid (Lunan Pharmaceutical), 20 mL tid po for 4 weeks.",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"TCM Syndrome Differentiation Decoction","Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Standard Treatment (Guideline-Based)","Combination therapy including: 1. Antiplatelet: aspirin 100 mg\u002Fday + clopidogrel 75 mg\u002Fday. 2. Lipid-lowering: atorvastatin 20 mg\u002Fday. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg\u002Fday). \\*Doses may be adjusted per local guidelines or patient tolerance.",[17],[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Tao Huang","CONTACT","18688898958","arteries@163.com",{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},"Zheng Zhen","19120517600","devotetcm@163.com",[52],{"facility":53,"status":28,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Guangdong Traditional Chinese Medicine Hospital","Guangzhou","Guangdong","510120","China","CN",{"type":60,"coordinates":61},"Point",[62,63],113.25,23.11667,{"lat":63,"lon":62},[66,68],{"name":67,"role":44,"phone":45,"phoneExt":28,"email":46},"Tao Huang, doctor",{"name":69,"role":44,"phone":49,"phoneExt":28,"email":50},"Zheng Zhen, master",{"type":71,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100599748","phase-4-traditional-chinese-medicine-intervention-for-ischemic-cardiovascular-disease-comorbid-with-diabetes-mellitus-an-efficacy-comparative-study-100599748",false,"NCT07088523","Traditional Chinese Medicine Intervention for Ischemic Cardiovascular Disease Comorbid With Diabetes Mellitus: An Efficacy Comparative Study","TICDEs","Inclusion Criteria:\n\n* Age\\>18 years;\n* Met the diagnostic criteria for myocardial infarction and type 2 diabetes mellitus;\n* Within 72 hours of myocardial infarction onset;\n* Met the diagnostic criteria of \"toxins damaging collaterals\"；\n* Voluntary participation in the study with consent forms signed.\n\nExclusion Criteria:\n\n* Long-term (\\>20 min) cardio-pulmonary resuscitation (CPR);\n* Critical illness due to STEMI (such as serious cardiogenic shock, uncontrolled acute left heart failure or pulmonary edema, malignant arrhythmias, explicit mechanical complications, etc. );\n* Suspected aortic dissection or acute pulmonary embolism;\n* 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;\n* Uncontrolled severe diabetic ketoacidosis;\n* Serious hepatic dysfunction or serious renal dysfunction ( ALT\u002FAST≥3 ULN or eGFR\\\u003C30mL\u002Fmin\u002F1.73 m2 or equiring dialysis );\n* Serious COPD or respiratory failure;\n* Severe infection (such as positive blood cultures, septic shock, and septic pneumonia, etc.);\n* Neuropsychiatric system diseases or unconscious and unable to cooperate with examination and treatment;\n* Malignancies or other conditions with expected survival time\\\u003C1 year or unsuitability to participate in this study due to other diseases;\n* Allergy to the ingredients of the research drugs;\n* Women who are in pregnancy or nursery;\n* Participation in clinical trial of other traditional Chinese medicine.","ALL","18 Years","80 Years",{"count":83,"type":84},4205,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","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).",[90,91],"Diabete Mellitus","Ischemic Cardiovascular Disease",[90,93,94,95],"Ischemic cardiovascular disease","real-world","Xintong Oral Liquid","NOT_YET_RECRUITING","2025-07-20",{"date":99,"type":100},"2025-07-28","ACTUAL",{"date":102,"type":84},"2025-07-31",{"date":104,"type":84},"2027-12-31",{"name":5,"class":6},1]