Acute ischemic stroke Circulatory System Stroke
Conditions
Interventions
This is a prospective, multicenter, randomized, open, assessor-blind study to assess the efficacy and safety of intra-arterial and intravenous thrombolysis in acute ischemic stroke patients within 3-9
Sponsors
Ministry of Science and Technology of the People's Republic of China (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. Clinical signs consistent with the diagnosis of ischemic stroke 3. Treatment onset within 3-9 hours after stroke onset 4. No prior neurologic event that would obscure the interpretation of the signal and current presenting neurologic deficits (modified Rankin scale [mRS] =1) 5. National Institutes of Health-Stroke-Scale (NIHSS) score >4 and at least moderate limb weakness 6. MRI screening to be started within 7.5 hours after stroke onset 7. Perfusion abnormality of >2 cm in diameter involving hemispheric gray matter 8. Perfusion/diffusion mismatch of =20 9. Magnetic resonance angiography (MRA) shows that TICI grade is 0 or 1
Exclusion criteria
Exclusion criteria: 1. Patients not eligible to receive trial treatment within 30-60 min after completion of MRI1 2. Coma 3. Stroke symptoms are rapidly improving by the time of randomization 4. Major stroke symptoms (>25 to 30 on the NIHSS) 5. History of stroke within the previous 6 weeks 6. Seizure at the onset of stroke 7. Stroke due to a neurointerventional procedure for treatment of a cerebral aneurysm and/or cerebral arteriovenous malformation (stroke due to diagnostic cerebral angiography or cardiac catheterization might be treated) 8. Clinical presentation suggestive of subarachnoid hemorrhage, even when the MRI is normal 9. History of intracerebral hemorrhage (ICH) at any time, neoplasm, subarachnoid hemorrhage (SAH), arteriovenous malformation (AVM) or aneurysm 10. Presumed septic embolus 11. Presumed pericarditis related to recent acute myocardial infarction 12. Recent (within 10 to 30 days) surgery, biopsy of a parenchymal organ, or lumbar puncture 13. Recent (within 10 to 30 days) trauma (including head trauma), with internal injuries or ulcerative wounds 14. Known active inflammatory bowel disease, ulcerative colitis, or diverticular disease 15. Any active or recent (within 10 to 30 days) hemorrhage 16. Known hereditary or acquired hemorrhagic diathesis. Baseline laboratory values that reveal platelets are 1.7. 17. Pregnancy, lactation, or parturition within the previous 30 days 18. Known serious sensitivity to radiographic contrast agents 19. Other serious, advanced, or terminal illness such that life expectancy is 180 mmHg or diastolic blood pressure =105 mmHg on 3 repeated measures at least 10 minutes apart. Aggressive treatment is defined as the need for a continuous, parenteral antihypertensive, such as a nitroprusside drip, or the need to administer >3 doses of a parenteral antihypertensive, such as labetalol or Urapidil. 22. Evidence of ICH or SAH 23. DWI abnormality involving >1/3 of middle cerebral artery (MCA) territory 24. No perfusion deficit 25. Any intracranial pathology interfering with the assessment of diffusion and perfusion abnormalities 26. Contraindications to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Imaging outcome: a. Reperfusion was assessed 24 to 48 hours posttreatment and defined as either >=30% reduction of mean transit time (MTT) volume of abnormality or >=2 points improvement on the TICI grading scheme using MRA b. The change in infarct lesion volume on DWI from baseline to 24 to 48 hours and 21 days 2. Clinical outcome: a. Global outcome at day 90: The combined analysis of the NIHSS, modified Rankin scale (mRS), and Barthel Index (BI) defined as =8 points improvement or scoring 0 to 1 on the NIHSS, a score of 0 to 2 on mRS, and a BI score of 75 to 100. Modified Rankin Scale 0-1, Barthel Index =95, NIHSS 0-1 (inclusive distal motor function) b. Disability status at day 90: mRS 0-2 (independent outcome), Barthel Index >=85 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional status at day 30: mRS (total score), median Barthel Index (total score), median NIHSS (total score), mean/median change from baseline NIHSS (8 points improvement or 0-1) 2. Functional status at day 7: NIHSS (total score), mean/median change from baseline NIHSS (4 points improvement or 0-1) 3. Functional status at 24 to 48 hours: NIHSS (total score), mean/median change from baseline 4. Functional status at day 0 (1 and 2 hours after treatment): NIHSS (total score), mean/median change from baseline 5. Stratified endpoint of NIHSS and mRS: NIHSS 14: mRS 0-2 response 6. Length of stay in hospital | — |
Countries
China
Outcome results
None listed