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 The study authors contributed unpublished data on participants with wake‐up stroke.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. |
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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 |