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

Abstract

Background: The risk of recurrence after a transient ischemic attack (TIA) or minor stroke is high especially within three months after the first event. The aim of the present study was to assess the efficacy of ticagrelor plus aspirin in reduction of mild non-cardioembolic ischemic stroke or high- risk TIA recurrence during the first 3 months.

Methods: This was a randomized, controlled, active comparator arm, outcome assessor blind, parallel group, study designed on 90 patients with diagnosis of non-cardioembolic mild ischemic stroke or high-risk TIA admitted in Bu-Ali Sina Hospital, Sari, Iran. After meeting all inclusion and exclusion criteria, patients were randomly assigned 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 were visited at month one and three. Any adverse events, serious side effects and outcome events were recorded. The primary outcome was defined as ischemic stroke recurrence.

Results: Ninety-four patients were recruited into this study (47 in ticagrelor and 47 in clopidogrel group). Stroke recurred in 2 patients in the clopidogrel group and no recurrence noted in the ticagrelor group (OR: 0.18; 95% CI = 0.008–3.932, P=0.27). No major hemorrhagic event occurred in either group.

Conclusion: Ticagrelor plus aspirin and clopidogrel plus aspirin showed similar efficacy and safety in preventing recurrence of mild non-cardioembolic stroke and high-risk TIA. However, uncertainties remain due to the small sample size, and larger trials are needed.