Sample size
stroke
MAY, BLIND, STILL, STROKE
This pilot study was based on the study carried out by Johnston and colleagues (2016) [We conducted our open-label randomized prospective controlled trial between May 2019 and September 2020 after approval of the ethical committee of the faculty of medicine at Ain Shams University and the ethical committee of the faculty of medicine Kafr El-Sheik University.We got formal written informed consent from all eligible patients or their first order of kin before randomization.We used a web-based centralized blocked randomization plan to randomly allocate patients in a one-to-one ratio to receive ticagrelor or aspirin. Still, all of the clinical investigators were blind to the block size of the randomization plan, but the patients were aware of the antiplatelet used in the study.The study was composed of two parallel groups: the ticagrelor group, which received a 180 mg loading dose during the first 9 h of stroke onset followed by 90 mg b.i.d from the second to the 90th day, and the aspirin group, which received a 300 mg loading dose during the first 9 h of stroke onset followed by 300 mg q.d. from the 2nd day to the 14th day then 75 mg q.d. from the 15th day to the 90th day.This analysis was specifically designed as a pilot study to examine the preliminary efficacy, safety, and feasibility of pursuing a large-scale randomized clinical trial powered properly for safety and efficacy.