Status:
COMPLETED
Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke
Lead Sponsor:
Hui-Sheng Chen
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can ef...
Eligibility Criteria
Inclusion
- Age \>18 years;
- Diagnosis of anterior circulation infarct;
- First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
- Time from onset to treatment ≤4.5 hours;
- SBP/DBP ≤ 180/110mmHg;
- No hemorrhagic imaging changes showed in CT;
- Signed informed consent by patient self or legally authorized representatives.
Exclusion
- History of stroke within 3 months;
- History of intracranial hemorrhage;
- Suspected subarachnoid hemorrhage;
- Intracranial tumour, vascular malformation or arterial aneurysm;
- Major surgery within 1 month;
- Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
- Platelet count \< 100×109／L;
- Heparin therapy or oral anticoagulation therapy within 48 hours;
- Severe disease with a life expectancy of less than 3 months;
- Blood glucose \< 50 mg/dL (2.7mmol/L);
- Patients who have received any other investigational drug or device within 3 months;
- Researchers consider patients inappropriate to participate in the registry. -
Key Trial Info
Start Date :
May 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03394950
Start Date
May 25 2018
End Date
May 29 2021
Last Update
June 2 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
General Hospital of ShenYang Military Region
Shenyang, China