AMI-DM
Conditions
Interventions
Treatment Group:Xintong Oral Liquid and Conventional medical therapy
Control Group:Xintong Oral Liquid placebo and Conventional medical therapy
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18–80 years, irrespective of sex. (2) Diagnosed with AMI (STEMI or NSTEMI) according to the aforementioned conventional diagnostic criteria, having undergone successful PCI within 72 hours of symptom onset. (3) Diagnosed with T2DM according to the aforementioned conventional diagnostic criteria. (4) Meeting the TCM diagnostic criteria for "Toxin Damaging the Heart Collaterals Syndrome" (Duxin Xinluo Zheng) as defined above. (5) Written informed consent was voluntarily provided (Informed Consent Form, ICF).
Exclusion criteria
Exclusion criteria: (1) Critically ill or near-death condition. (2) Cardiopulmonary resuscitation (CPR) duration >20 minutes. (3)Suspected aortic dissection or acute pulmonary embolism. (4)Significant mechanical complications of AMI (e.g., papillary muscle rupture, ventricular septal rupture, pseudoaneurysm, free wall rupture). (5) Refractory cardiogenic shock unresponsive to vasopressor therapy. (6)Uncontrolled acute left ventricular failure or pulmonary edema. (7)Malignant arrhythmias refractory to antiarrhythmic medication. (8)HbA1c > 10% (>86 mmol/mol). (9)History of malignancy. (10)High risk of severe bleeding, including hemorrhagic diathesis, severe coagulopathy, history of major bleeding (cerebral, gastrointestinal, respiratory, genitourinary, or other organ systems) within the past month, or active bleeding (including menstruation) at presentation. (11) Known allergy or hypersensitivity to the investigational product or its components. (12)Pregnant or lactating women. (13)Concurrent participation in another clinical trial involving Chinese herbal medicine, or current use of herbal medicines categorized as promoting blood circulation and resolving toxin. (14)Severe hepatic or renal dysfunction (serum alanine aminotransferase [ALT] or serum creatinine >3 times the upper limit of normal [ULN]).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year incidence of Major Adverse Cardio-Cerebrovascular Events (MACCE) , Include composite of cardiac death, recurrent MI, ischemia-driven revascularization, stroke, ACS rehospitalization.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year incidence of minor adverse cardiovascular events;echocardiogram;NT-proBNP;glycated hemoglobin level;SF-36 questionnaire;Seattle Angina Scale;Pittsburgh Sleep Quality Index;Number of new cases of diabetic kidney disease;endogenous creatinine clearance; | — |
Countries
china
Contacts
Public ContactDawu Zhang
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed