Clinical Study on Floium Ginkgo Extract and Tertram Ethypyrazine Sodium Chloride injection in Treatment of Acute Ischemic Stroke
- Conditions
- acute ischemic stroke
- Registration Number
- ITMCTR1900002858
- Lead Sponsor
- The First Hospital of China Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1) aged >= 18 years;
2) acute ischemic stroke patients with first symptom onset;
3) symptom onset within 4.5 hours and eligible for criteria for IV-tPA treatment;
4) baseline NIHSS score range from 7 to 22;
5) written informed consent has been provided by patients or their legal proxies.
1) Allergic to the drug components in this study.
2) Oral or intravenous application of other drugs similar to the mechanism of Floium Ginkgo Extract and Tertram Ethypyrazine Sodium Chloride injection before stroke onset(28 days).
3) Epilepsy with stroke onset.
4) Other lesions in the brain, history of mental illness.
5) History of chronic liver disease, liver and kidney dysfunction, elevated alanine aminotransferase (> 3 times the upper limit of normal), and elevated serum creatinine (> 2 times the upper limit of normal).
6) Pregnant or lactating women.
7) Other severe, advanced or terminal illnesses with life expectancy of less than 3 months, or inability to complete study follow-up due to other reasons.
8) Other circumstances that the researchers consider not appropriate for this study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method reperfusion improvement;
- Secondary Outcome Measures
Name Time Method Rate of adverse events;Vascular recanalization;Ischemic penumbra;proportion of patients with a mRS score of 0-2;Proportion of patients with a NIHSS score at day 15, day 30, day 90 of 0-1 or a reduction of = 8 points from baseline;proportion of patients with a Barthel score=95;