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. 2021 Dec 1;2021(12):CD010995. doi: 10.1002/14651858.CD010995.pub3

ECASS‐4.

Study characteristics
Methods Randomised, multicentre, double‐blind, placebo‐controlled, phase 3 trial
Participants Patients with acute ischaemic stroke could be included if treatment could be started within 4.5 to 9 hours after symptom onset. Patients who woke up with stroke symptoms could be included if the mean between time last seen well and symptom recognition was between these limits. The NIHSS score had to be between 4 and 26, and the penumbral MRI had to demonstrate a perfusion volume (PWI) to infarct core (DWI) ratio of 1.2, and a perfusion lesion minimum volume of 20 ml.The trial included 119 participants, of whom 63 had wake‐up stroke. The study authors contributed unpublished data on participants with wake‐up stroke.
Interventions Participants were randomised to either intravenous thrombolysis with rt‐PA, alteplase (0.9 mg/kg) or placebo.
Outcomes Primary endpoint was categorical shift in the mRS at day 90.
Secondary endpoints were favourable outcome mRS 0 to 1 versus unfavourable outcome 2 to 6, improvement of neurological status measured by NIHSS, reperfusion at 12 to 24 hours after treatment.
Notes Funding source: no financial support for the research, authorship, or publication of main article
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Low risk Web‐based randomisation
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind and placebo controlled
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias)
All outcomes Low risk No participants lost to follow‐up
Selective reporting (reporting bias) Low risk Intention‐to‐treat analysis was provided.
Other bias Unclear risk Stopped early because of slow recruitment after 119 of 264 planned participants