![]() ![]() ).Knowingly ≠ unknowingly knowledgeably From Longman Dictionary of Contemporary English unknown un‧known 1 / ˌʌnˈnəʊn◂ $ -ˈnoʊn◂ / (Funded by the European Union Seventh Framework Program WAKE-UP number, NCT01525290 and EudraCT number, 2011-005906-32. In patients with acute stroke with an unknown time of onset, intravenous alteplase guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia resulted in a significantly better functional outcome and numerically more intracranial hemorrhages than placebo at 90 days. The rate of symptomatic intracranial hemorrhage was 2.0% in the alteplase group and 0.4% in the placebo group (odds ratio, 4.95 95% CI, 0.57 to 42.87 P=0.15). The median score on the modified Rankin scale at 90 days was 1 in the alteplase group and 2 in the placebo group (adjusted common odds ratio, 1.62 95% CI, 1.17 to 2.23 P=0.003). A favorable outcome at 90 days was reported in 131 of 246 patients (53.3%) in the alteplase group and in 102 of 244 patients (41.8%) in the placebo group (adjusted odds ratio, 1.61 95% confidence interval, 1.09 to 2.36 P=0.02). Of these patients, 254 were randomly assigned to receive alteplase and 249 to receive placebo. The trial was stopped early owing to cessation of funding after the enrollment of 503 of an anticipated 800 patients. A secondary outcome was the likelihood that alteplase would lead to lower ordinal scores on the modified Rankin scale than would placebo (shift analysis). The primary end point was favorable outcome, as defined by a score of 0 or 1 on the modified Rankin scale of neurologic disability (which ranges from 0 to 6 ) at 90 days. We excluded patients for whom thrombectomy was planned. All the patients had an ischemic lesion that was visible on MRI diffusion-weighted imaging but no parenchymal hyperintensity on fluid-attenuated inversion recovery (FLAIR), which indicated that the stroke had occurred approximately within the previous 4.5 hours. ![]() In a multicenter trial, we randomly assigned patients who had an unknown time of onset of stroke to receive either intravenous alteplase or placebo. We sought to determine whether patients with stroke with an unknown time of onset and features suggesting recent cerebral infarction on magnetic resonance imaging (MRI) would benefit from thrombolysis with the use of intravenous alteplase. Under current guidelines, intravenous thrombolysis is used to treat acute stroke only if it can be ascertained that the time since the onset of symptoms was less than 4.5 hours. ![]()
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