acute ischemic stroke
Conditions
Interventions
PUK50(4.5h) group:50mg pro-UK for patients within 4.5h of AIS
PUK35(4.5h) group:35mg pro-UK for patients within 4.5h of AIS
PUK50(6h) group:50mg pro-UK for patients from 4.5h to 6h of AIS onset
PUK35 (6h) group:35mg pro-UK for patients from 4.5h to 6h of AIS onset
RTPA (4.5h) group:0.9mg/kg rt-PA for patients within 4.5h of AIS
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ischemic stroke with symptoms of neurological deficits; 2. Aged 18 to 80 years, male or female; 3. NIH Stroke Scale(NIHSS)scores of 4 to 25; 4. Treatment within 6 hours after stroke onset. Stroke onset time is defined as the last time a patient with no clinical neurological deficit,for patients who wake up with stroke symptoms, consider that stroke occurs when the patient begins to fall asleep; 5. The symptoms of stroke last at least 30 minutes without significant improvement before treatment; 6. CT shows negative or signs of early infarction; 7. Patients and/or their families are willing to participate in this study and agree to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. The duration from the onset of stroke symptoms to thrombolysis was > 6 hours; 2. CT shows multiple infarctions (low density> 1/3 cerebral hemisphere); 3. Intracranial hemorrhage or subarachnoid hemorrhage on baseline; 4. Transient ischemic attack; 5. Epileptic seizure when stroke onset; 6. Active visceral hemorrhage; 7. Intracranial tumor, arteriovenous malformation and aneurysm; 8. Stroke due to treatment of intracranial aneurysm or arteriovenous malformation by interventional therapy operation(Stroke due to diagnostic cerebral angiography or cardiac intervention should be treated); 9. Cardiogenic embolism; 10. Puncture in 1 week which can not be oppressed; 11. Major surgery or severe trauma within 2 weeks; 12. Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days; 13. Myocardial infarction history within 3 months; 14. Severe cerebral trauma or stroke history within 3 months; 15. Blood pressure is still out of control after aggressive antihypertensive treatment.Uncontrolled blood pressure is defined as systolic blood pressure= 180mmHg or diastolic blood pressure =100mmHg at least 10 minutes interval and repeated three times; 16. Heparin treatment within 48 hours (APTT above normal upper limit); 17. Taking anticoagulant drugs orally, and PT >15s or INR >1.7; 18. High risk of acute hemorrhage,including platelet count 22.2 mmol/L; 21. Patients with intracerebral hemorrhage history; 22. Pregnancy, lactating or menstrual women; 23. Patients with diabetic retinopathy history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Rankin scale scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| modified Rankin scale scores;NIHSS changes;Barthel Index;Recurrence of stroke within 7 day after treatment; | — |
Countries
China
Contacts
Public ContactYuping Wang
Xuanwu Hospital Capital Medical University,
Outcome results
None listed