minor ischemic stroke or transient ischemic attack
Conditions
Interventions
Control group:Placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine (The Second Hospital affiliated to Guangzhou University of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged >= 40 years with high-risk TIA (ABCD2 >= 4) or minor ischemic stroke (NIHSS <= 3) who can be randomized and treated within 24 hours of symptom onset, and participants signed the writtent informed consent forms.
Exclusion criteria
Exclusion criteria: If one of the following conditions is met, it shall not be excluded: 1. According to the baseline cranial CT or MRI, diagnoses were made for hemorrhage or other pathological brain diseases, such as vascular malformations, tumors, abscesses or other common non-ischemic brain diseases. 2. If there is no evidence of acute infarction on CT or MRI at baseline, one of the following conditions should be excluded. 2.1 sensory symptoms only (e.g. numbness); 2.2 visual changes only; 2.3 dizziness or vertigo only. 3. TIA or mild stroke caused by angioplasty or vascular surgery. 4. According to the pre-onset history evaluation, mRS score was more than 2 points. 5. Intravenous or arterial thrombolysis and mechanical thrombectomy were performed within 24 hours before admission. 6. Two or more antiplatelet drugs were taken within 72 hours before enrollment. 7. Heparin or oral anticoagulant drugs were used within 10 days before enrollment. 8. There was a history of gastrointestinal hemorrhage within 3 months before admission or major surgery was performed within 30 days. 9. Active stage of peptic ulcer. 10. History of intracranial hemorrhage. 11. History of aneurysms (including intracranial aneurysms and peripheral aneurysms). 12. Coagulation dysfunction with clinical significance. 13. History of coagulation disorders or systemic haemorrhage (e.g. hemophilia, von Willebrand disease, vitamin K deficiency, and Allergic purpura, etc.). 14. Clear indication of anticoagulation therapy (suspected cardiogenic embolism, such as atrial fibrillation, known artificial heart valve, etc.) of the patients. 15. Based on the medical history and clinical data at the time of enrollment, surgery or endovascular treatment is expected to be performed in the next 3 months. 16. Other planned surgical or interventional treatments may require discontinuation of the trial drug. 17. Long term (> 7 days) use of non-experimental antiplatelet agents or NSAIDs other than aspirin are expected. 18. Allergic to Dengzhan Shengmai capsule, aspirin or clopidogrel. 19. Severe liver or renal impariments (ALT or AST > 2 times normal upper limit; Cre> 1.5 times of the normal upper limit). 20. Severe heart failure (NYHA grade III or NYHA IV). 21. Confirmed or suspected acute coronary syndrome. 22. Severe non-cardio-cerebrovascular diseases, with an estimated survival time of less than 3 months. 23. Unable to cooperate with the study due to mental illness, cognitive or emotional disorders. 24. Participated in other clinical drug trials in the past 30 days. 25. Under experimental drug or instrument test. 26. Women of childbearing age with positive pregnancy test, women of childbearing age with negative pregnancy test but refusing to take effective contraceptive measures, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New stroke event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Activities of daily living;Neurological impairments;New vascular event;New ischemic stroke;Disability;Quality of life; | — |
Countries
China
Contacts
Public ContactYefeng Cai
Guangdong Provincial Hospital of Chinese Medicine (The Second Hospital affiliated to Guangzhou University of Chinese Medicine)
Outcome results
None listed