NASHVILLE—Tissue plasminogen activator (t-PA) appears to be safe in the treatment of stroke detected when people wake up in the morning, according to a multicenter, prospective study presented at the 2015 International Stroke Conference.
A significant number of ischemic strokes is noticed upon awakening. Patients with this type of stroke are not generally considered candidates for IV t-PA because the treatment must be delivered within three hours of stroke onset, and the time of stroke onset is unknown for these patients.
Andrew D. Barreto, MD, Assistant Professor in the Department of Neurology at the University of Texas Health Science Center in Houston, and colleagues conducted a multicenter, single-arm, prospective, open-label study to evaluate the safety of IV thrombolysis in wake-up stroke.
Patients enrolled in the study had a broad range of stroke severities and levels of disability. Study participants were between the ages of 18 and 80, had an NIH Stroke Scale (NIHSS) score of 25 or lower, and were selected solely according to the appearance of noncontrast CT. A standard dose (0.9 mg/kg) of IV t-PA had to be started three hours or fewer after the patient awakened (average time 2.6 hours).
The primary safety outcome was symptomatic intracerebral hemorrhage. Other end points included asymptomatic intracerebral hemorrhage, clinical improvement in NIHSS, and 90-day modified Rankin Scale score. The study had preplanned stopping rules and data safety board oversight.
Among 40 treated patients, none had intracerebral hemorrhage resulting in neurologic worsening. Half of the patients had made full recoveries after their stroke when followed-up at 90 days.
“Intravenous thrombolysis appears to be safe in wake-up stroke patients selected by noncontrast CT,” Dr. Barreto and colleagues reported. “A randomized effectiveness trial appears feasible using a similar, pragmatic design.”
—Glenn S. Williams