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Randomized Controlled Trial
. 2023 Feb;44(2):765-771.
doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30.

A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke

Hany M Aref  1 , Hala El-Khawas  1 , Ahmed Elbassiouny  1 , Hossam M Shokri  1 , Mohamed G Zeinhom  2 , Tamer M Roushdy  1
Affiliations
Randomized Controlled Trial

A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke

Hany M Aref et al. Neurol Sci. 2023 Feb.

Abstract

Background: Ticagrelor is one of the most recent antiplatelet drugs to be approved to treat ischemic heart disease. Its efficacy may exceed aspirin in improving clinical outcomes in patients with acute ischemic stroke who are ineligible for rt-PA.

Objectives: We evaluated the safety regarding hemorrhagic complications (as a primary endpoint) and the efficacy (as a secondary endpoint) of a 180-mg loading dose of ticagrelor given within 9 h from the onset of the first-ever non-cardioembolic ischemic stroke.

Methods: We conducted our study on patients aged 18-75 years who presented with their first clinically manifested non-cardioembolic ischemic stroke and were recruited from the emergency department OF Kafr El-Sheik University Hospitals, Egypt. Eligible patients randomly received ticagrelor or aspirin loading and maintenance doses. Screening, randomization, and initiation of treatment all occurred within the first 9 h of stroke onset.

Results: Eighty-five patients received ticagrelor, and 84 received aspirin. Patients who received ticagrelor had a better clinical outcome in terms of NIHSS improvement at 2 days and 1 week of discharge and a favorable mRS score after 1 week of discharge and at 90-day follow-up. There was no significant difference between the two groups regarding hemorrhagic adverse effects.

Conclusion: This pilot study found that ticagrelor had a better clinical outcome than aspirin based on NIHSS and mRS in acute ischemic stroke patients who received it within 9 h from symptom onset and had a shorter hospital stay duration. Ticagrelor was non-inferior to aspirin regarding hemorrhagic complications.

Trial registration: We registered our trial on ClinicalTrials.gov, named after "ticagrelor versus aspirin in ischemic stroke," and with a clinical trial number (NCT03884530)-March 21, 2019.

Keywords: Acute ischemic stroke; Egypt; Ticagrelor; Ticagrelor versus aspirin.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study flow diagram
See this image and copyright information in PMC

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