Thrombolysis May Be Appropriate in Wake-Up Stroke
The randomized controlled WAKE-UP trial, a phase III study of 503 patients with acute stroke of unknown time of symptom onset, assessed whether or not advanced imaging can be used to increase the number of patients eligible for potent clot-busting drugs to include patients waking with a stroke.
The WAKE-UP study showed that in patients with stroke and unknown time of symptom onset and an MRI pattern demonstrating DWI-FLAIR-mismatch, indicating a likely recent time of onset, treatment with alteplase resulted in a better functional outcome at 90 days in an additional 11% of treated patients, compared with placebo, despite an increased risk of intracerebral hemorrhage. The effect size of MRI-guided thrombolysis in stroke with unknown time of symptom onset is comparable to the effect size of thrombolysis administered at less than 4.5 hours. The researchers observed a trend towards an increased risk of early death, however.
The joint lead investigators of WAKE-UP commented on the results. “These data represent a paradigm shift in the treatment of stroke patients with an unknown time of symptom onset,” said Professor Christian Gerloff, MD, Director of Neurology at University Hospital Hamburg-Eppendorf in Germany. “It is the first positive trial of IV thrombolysis relying on patient selection by advanced brain imaging without information on time of symptom onset.”
“MRI-guided IV thrombolysis represents an effective treatment option for stroke patients with unknown [time of] symptom onset, especially for those with minor or moderate stroke who are not eligible for mechanical thrombectomy,” said Götz Thomalla, MD, Executive Senior Physician at University Hospital Hamburg-Eppendorf.