ischemic stroke
Conditions
Interventions
Experimental group:Xuesaitong soft capsules and aspirin enteric-coated tablets
Control group:Xuesaitong soft capsules simulants and aspirin enteric-coated tablets
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for this clinical trial, subjects must meet all of the following criteria: (1) aged 18 to 75 years old; (2) within 14 days after onset of ischemic stroke; (3) pre-stroke mRS score of 0 to 1; (4) NIHSS score of 4 to 15 at randomization; (5) Signed the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are ineligible for enrollment in the clinical trial: 1. Head CT or MRI found bleeding or other pathological brain disorder such as vascular malformation, tumor, abscess, encephalitis, or other common non-ischemic brain diseases (e.g., multiple sclerosis); 2. There are contraindications for using Xuesaitong soft capsules and aspirin enteric-coated tablets: 1) Those who are known to have a history of allergies; 2) Allergic to aspirin or other salicylates, or any other ingredient of the drug; 3) History of asthma caused by salicylates or salicylates, non-steroidal anti-inflammatory drugs; 4) Active peptic ulcer; 5) Severe liver insufficiency or renal insufficiency (ALT>2 times the upper limit of normal or AST>2 times the upper limit of normal; creatinine>1.5 times the upper limit of normal); 6) Severe heart failure; 7) History of coagulopathy or systemic hemorrhage; 8) History of previous thrombocytopenia or neutropenia; 9) Previous history of drug-induced blood system disorders or abnormal liver function; 10) Leukopenia (<2x10^9/L) or thrombocytopenia (<100x10^9/L); 11) Pregnancy and lactation women; 3. Have clear indications for anticoagulant therapy (suspected cardiogenic embolisms such as atrial fibrillation, known prosthetic heart valves, suspicious endocarditis, etc.); 4. History of intracranial hemorrhage or history of amyloid cerebrovascular disease; 5. History of aneurysm (including intracranial aneurysm, peripheral aneurysm); 6. Diagnosis or suspected acute coronary syndrome; 7. High-risk bradyarrhythmias, such as secondary or third-degree atrioventricular block in patients with sick sinus syndrome, and bradycardia in the absence of pacemaker-related syncope; 8. History of digestive tract bleeding within 3 months prior to randomization or major surgery within 30 days; 9. Surgical or endovascular treatment is expected within the next 3 months; 10. Other surgical or interventional treatment planned may require termination of the test drug; 11. Suffering from serious non-cardio-cerebrovascular diseases, the expected survival time is less than 3 months; 12. Women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures; 13. Being tested for experimental drugs or instruments; 14. Participated in other clinical drug studies in the past 30 days; 15. Inability to understand and/or follow research procedures and/or follow-up due to mental disorders, cognitive or emotional disorders; 16. Other patients who are considered inappropriate to participate in the study by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of good functional outcome (mRS<=2);Proportion of serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stroke (cerebral infarction, cerebral hemorrhage) recurrence rate;Proportion of good functional outcome (mRS<=2);mRS 0-1 ratio;Changes in NIHSS scores;The proportion of combined vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death);Quality of Life Score (EQ-5D);Changes in daily life activity capacity(Barthel Index);Platelet count, coagulation index (prothrombin time, activated partial thromboplastin time);Pharmacoeconomic evaluation;The proportion of symptomatic bleeding;The proportion of all-cause deaths;The proportion of adverse events; | — |
Countries
China
Contacts
Public ContactXunming Ji
Xuanwu Hospital Capital Medical University
Outcome results
None listed