Clinical Trials
WAKE-UP
Acronym: Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke
Purpose: Researchers assessed safety and efficacy of MRI-based IV thrombolysis with alteplase (Activase, Genentech) in patients with acute stroke.
Format: Randomized, double-blind, placebo-controlled
Treatment Group: MRI-based IV thrombolysis with alteplase
Control group: Placebo
Number of Participants: 503
Centers: 7
Inclusion Criteria: An ischemic lesion that was visible on MRI diffusion-weighted imaging but no parenchymal hyperintensity on FLAIR
Exclusion Criteria: Patients with planned thrombectomies
Primary Outcome(s): Favorable outcome, as defined by a score of 0 or 1 on the modified Rankin scale of neurologic disability at 90 days
Secondary Outcome(s): Likelihood that alteplase would lead to lower ordinal scores on the modified Rankin scale vs. placebo
Summary: At 90 days, a favorable outcome was observed in 53.3% of patients in the alteplase group and in 41.8% of patients in the placebo group (adjusted OR = 1.61; 95% CI, 1.09-2.36) and there was a median score on the modified Rankin scale of 1 in the alteplase group and 2 in the placebo group (adjusted common OR = 1.62; 95% CI, 1.17-2.23). In the alteplase group, 4.1% of patients died vs. 1.2% in the placebo group (OR = 3.38; 95% CI, 0.92-12.52).
Original Publication:
Thomalla G, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1804355.
Link to Cardiology Today Article: