Ticagrelor plus aspirin vs clopidogrel plus aspirin in mild non-cardioembolic ischemic stroke: A protocol of a randomized, controlled, active comparator arm, outcome assessor blind, feasibility study

Background & Objectives: The risk of recurrence after a transient ischemic attack (TIA) or minor stroke is high especially within three months after first event. The aim of study is assessing the efficacy of ticagrelor plus aspirin in reduction of mild non-cardioembolic ischemic stroke or high risk TIA recurrence during first 3 months. Methods: This is a randomized, controlled, active comparator arm, outcome assessor blind, parallel group, feasibility study design on 90 patients with diagnosis of non-cardioembolic minor ischemic stroke or high risk TIA admitted in Bou-Ali Sina Hospital, Sari, Iran. After meeting all inclusion and exclusion criteria, patients will be randomized to ticagrelor 90 mg BID plus aspirin (ASA) 80 mg daily or clopidogrel 75 mg daily plus ASA 80 mg daily (1:1 ratio) until 21 days and then ASA 80 mg daily. Participants will be visited at month one and three. Any adverse events, serious side effects and outcome events will be recorded. The primary outcome is defined as ischemic stroke recurrence. Conclusion: Ticagrelor plus ASA is expected to be effective for prevention of recurrence in mild non-cardioembolic stroke and high risk TIA. Trial Registration: ClinicalTrials.gov: NCT04738097