Acute Ischemic Cerebral Stroke
Conditions
Interventions
Test:Cinepazide Maleate Injection
Controlled:Placebo: Distilled Water
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. patients' age between: 18-75; 2. patients with ischemic stroke (followed diagnostic criteria of ischemic stroke in Chinese Guidelines for diagnosis and treatment in acute ischemic stroke); 3. patients with ischemic stroke of internal carotid artery within 48 hours; 4. NIHSS score 4 to 25; 5. signature of informed consent form.
Exclusion criteria
Exclusion criteria: 1. patients those neural imaging checks(CT/MRI) confirmed acute intracranial hemorrhage, tumor, encephalitis or other non-acute ischemic stroke; 2. patients with hypertension: systolic blood pressure >=180mmHg or diastolic blood pressure >=120mmHg; 3. patients with diabetic: glucose levels 16.8mmol/L with hypoglycemic ; or diabetes-induced neurological impairment, peripheral neuropathy, Diabetic Gangrene; 4. patients with severe liver damage, those ALT or AST level is 3 times higher than normal amount; 5. patients with severe renal impairment (creatinine =2 before attack; 10. patients with obvious mass effect, CT or MRI signs of midline structures; CT sign shows massive ischemic stroke (more than 1 brain or more than 1/3 of middle cerebral artery blood supply region); 11. patients with bleeding or severe bleeding occurred within 3 months; 12. patients with allergies; the test drug or ingredient allergies; 13. patients with suspicion or do have a history of alcohol or drug abuse, or according to the researcher's judgment, can reduce the set of possibilities or made into a complicated set of other circumstances; 14. pregnant women and lactating mothers, urine pregnancy test positive or are planning in the near future; 15. patients with any contraindications to MRI (metal implants such as pacemakers, cabin fever phobia, etc); 16. patients those are participating in clinical trials or participated in other clinical drug trial ended not more than 3 months; 17. patients with critical condition, whose expectancy life is less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients those NIHSS score improved than 4 or more, or those NIHSS scroe reduced to 0 or 1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients those modified Rankin scale (mRS) score less than 1;Neurological damage;Proportion of patients those Barthel index (BI) ratio more than 90;EQ-5D scale; | — |
Countries
China
Contacts
Public ContactWang Yongjun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed