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: