Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke

WAKE-UP was a European multicentre investigator-initiated randomized placebo-controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening.

WAKE-UP was a European collaborative research project launched by a consortium of academic and SME partners. The trial involved 70 study centers from 8 European countries. Of 1,362 patients screened by MRI, 503 were randomized to treatment with intravenous alteplase or placebo. The primary end point was favorable outcome, as defined by a score of 0 or 1 on the modified Rankin scale (mRS) of neurologic disability.

WAKE-UP demonstrated efficacy and safety of treatment with intravenous alteplase in patients with acute stroke with an unknown time of onset, who had a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia (DWI-FLAIR mismatch) (Thomalla et al., 2018). The results of the trial have led to changes in guideline recommendations and clinical practice. WAKE-UP received funding by the European Union Seventh Framework Program

ClinicalTrials.gov Identifier, NCT01525290