Data were obtained from MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands)14 (link) and the IMS (Interventional Management of Stroke) III trial.15 (link) Anonymized trial data and methods that support our study findings are available for MR CLEAN upon reasonable request to mrclean@erasmusmc.nl and via the public dataset through National Institutes of Health for the IMS III trial (https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinical-Research/Archived-Clinical-Research-Datasets). MR CLEAN was a phase III, multicenter, open-label RCT that evaluated the efficacy and safety of EVT plus usual care (intervention) compared with usual care alone (control) in patients with acute ischemic stroke. MR CLEAN enrolled 500 patients from 16 intervention centers in the Netherlands between December 2010 and March 2014. Enrolled patients were aged ≥18 years, had an ischemic stroke due to an intracranial large vessel occlusion in the anterior circulation with an NIHSS score of ≥2, and were able to undergo EVT within 6 hours after symptom onset. The central medical ethics committee and research board of each participating center approved this study. All patients or their legal representatives provided written informed consent before randomization. The IMS III trial was a phase III, multicenter, open-label RCT, evaluating whether EVT combined with intravenous thrombolysis (IVT) with recombinant tissue-type plasminogen activator in a dose of 0.6 mg/kg (intervention) within 3 hours of symptom onset was superior to IVT alone (control). The IMS III trial enrolled 656 patients from 58 international centers between August 2006 and April 2012, aged 18 to 80 years with a moderate-to-severe ischemic stroke (NIHSS ≥10) before initiation of IVT. The study was approved by the ethics committee and research board of each participating center. Written informed consent was obtained from patients or their legal representative before enrollment in the study.
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Chalos V., van der Ende N.A., Lingsma H.F., Mulder M.J., Venema E., Dijkland S.A., Berkhemer O.A., Yoo A.J., Broderick J.P., Palesch Y.Y., Yeatts S.D., Roos Y.B., van Oostenbrugge R.J., van Zwam W.H., Majoie C.B., van der Lugt A., Roozenbeek B, & Dippel D.W. (2019). National Institutes of Health Stroke Scale: An Alternative Primary Outcome Measure for Trials of Acute Treatment for Ischemic Stroke. Stroke, 51(1), 282-290.
Other organizations :
Erasmus MC, University of Amsterdam, Amsterdam University Medical Centers, Maastricht University, University of Cincinnati, Medical University of South Carolina
Endovascular treatment (EVT) plus usual care (intervention)
Usual care alone (control)
dependent variables
Efficacy and safety of EVT
control variables
Patients with acute ischemic stroke due to an intracranial large vessel occlusion in the anterior circulation with an NIHSS score of ≥2
Patients able to undergo EVT within 6 hours after symptom onset
positive control
Intravenous thrombolysis (IVT) with recombinant tissue-type plasminogen activator in a dose of 0.6 mg/kg (control)
negative control
Not explicitly mentioned
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