Mayo Acute Stroke Trial for Enhancing Recovery (MASTER) Protocol

Background

Stroke is the leading cause of acquired disability in adulthood. Ischemic stroke often results in physical, emotional, and cognitive impairment. There is no definitively proven pharmacologic technique to accelerate recovery from stroke. The short-term goal of this study is to develop donepezil hydrochloride as pharmacotherapy for enhancing stroke recovery.

Design

The Mayo Acute Stroke Trial for Enhancing Recovery (MASTER) is a prospective, stratified 2-stage trial of donepezil for acute ischemic stroke. Suitable patients must receive treatment within 24 hours of developing symptoms. A total of 30 to 40 patients will be enrolled.

Trial Procedures

Participants will receive up to 10 mg of donepezil daily for 90 days. Patients will be assessed at less than 24 hours (pretreatment), 30 days, 60 days, 90 days, and 6 months off-drug poststroke. Assessments will include examinations of neurologic, cognitive, functional, and psychological status. The primary outcome will be excellent neurologic recovery, defined as National Institutes of Health Stroke Scale score of 0 or 1 at 90 days after stroke. Secondary outcome measures are the proportion of patients with favorable outcomes defined as follows: National Institutes of Health Stroke Scale score of 0 or 1 at 6 months; modified Rankin scale score of 0 or 1 at 90 days and 6 months; modified Rankin scale score less than 3 at 90 days and 6 months; and Mini-Mental State Examination score greater than 24 at 90 days and 6 months.

Trial Registration

Clinicaltrials.gov identifier NCT00805792.

Key Words: Donepezil, ischemic stroke, National Institute of Neurological Disorders and Stroke tissue plasminogen activator trial, recovery, rehabilitation, phase II trial