Article Figures & Data
- Figure 1
Trial flow chart. CTP, CT perfusion; DWI, diffusion-weighted imaging; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; R, randomisation; rt-PA, recombinant tissue plasminogen activator.
- Table 1
Inclusion and exclusion criteria
Inclusion criteria Exclusion criteria 1. Patients presenting with clinical signs of AIS within 4.5–24 hours from symptom onset (for stroke with unknown time of onset, the midpoint of the time last known to be well and symptom recognition time; for wake-up stroke, the midpoint of sleep onset or the time last known to be well and wake up time). 1. Intracranial haemorrhage shown on CT. 2. Age over 18 years. 2. Large (more than one-third of the territory of MCA) region of clear hypodensity on CT scan. 3. NIHSS range from 4 to 26. 3. Prestroke mRS score of >1. 4. Imaging inclusion criteria: ischaemic core volume ≤70 mL, penumbra ≥10 mL and mismatch ≥20% (as evaluated by CT perfusion). 4. Other contraindications for alteplase.* 5. Informed consent from patient, family member or legally responsible person depending on local ethics requirements. 5. Intend to undertake endovascular therapy. 6. A life expectancy of less than 3 months. 7. Any other condition that could significantly increase the risk of severe bleeding (such as haemolytic uraemic syndrome or thrombotic thrombocytopenic purpura). The judgement is left to the discretion of investigators. *Other contraindications for alteplase is in accordance with the latest Chinese guidelines for AIS management (detailed in online supplemental materials).
AIS, acute ischaemic stroke; ICH, intracerebral haemorrhage; MCA, middle cerebral artery; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
- Table 2
Schedule of assessments
Study period Randomisation Postrandomisation Follow-up Time point Baseline 24 hours 7 days 90 days Informed consent form ✓ Demographic data ✓ Comorbidity and medical history ✓ NIHSS ✓ ✓ ✓ ✓ Vital signs ✓ Routine laboratory assessments* ✓ ✓ Imaging CTP NCCT/DWI NCCT/DWI Adverse event assessment ✓ ✓ Modified Rankin Scale Pre-stroke ✓ Barthel Index ✓ EUROQOL 5D-5L ✓ *Routine laboratory assessments include coagulation profile, complete blood count and clinical chemistry (glucose, lipid profile, electrolytes, urea).
CTP, CT perfusion; EUROQOL 5D-5L, EuroQoL 5-dimenslons 5-lavel; DWI, diffusion-weighted imaging; NCCT, non-contrast CT; NIHSS, National Institutes of Health Stroke Scale.
Supplementary Materials
Supplementary data
Additional Files
Supplementary Data
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