THALES PRIMARY EFFICACY END POINT

In patients with acute ischemic stroke (NIHSS ≤5) or high-risk TIA, BRILINTA showed a greater reduction in the composite of subsequent stroke or death vs aspirin alone1,2

THALES primary efficacy end point (composite of stroke or death at 30 days)

THALES Primary Efficacy End Point
THALES Primary Efficacy End Point
  • The composite end point was driven by the stroke component of the primary end point (19% RRR, 1.1% ARR)2
  • BRILINTA is not indicated to reduce death in patients with acute ischemic stroke or high-risk TIA2
  • BRILINTA’s treatment effect on stroke and on death accrued over the first 10 days and was sustained at 30 days. Although not studied, this suggests that shorter treatment could result in similar benefit and reduced bleeding risk2

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THALES STUDY DESIGN

THALES was a randomized, international, double-blind, placebo-controlled, multicenter study to investigate dual antiplatelet therapy with BRILINTA (180-mg loading dose, 90 mg twice daily thereafter) and aspirin vs placebo and aspirin in the prevention of stroke or death in patients with acute ischemic stroke or transient ischemic attack (N=11,016). The primary end point was the first occurrence of the composite of stroke or death at 30 days. In both arms, patients received a loading dose of aspirin 300-325 mg followed by aspirin 75-100 mg once daily. Patients were ≥40 years of age, had mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5), or high-risk TIA (ABCD2 score ≥6 or symptomatic intracranial or extracranial arterial stenosis [≥50% narrowing in the diameter of the lumen of an artery that could account for the TIA]). Patients were randomized within 24 hours and treated for a median of 31 days.1,2

ABCD2=Age, Blood pressure, Clinical features, Duration of TIA, and Diabetes mellitus; ARR=absolute risk reduction; CI=confidence interval; HR=hazard ratio; K-M=Kaplan-Meier; NIHSS=National Institutes of Health Stroke Scale; NNT=number needed to treat; RRR=relative risk reduction; THALES=Acute STroke or Transient IscHemic Attack Treated with TicAgreLor and Aspirin for PrEvention of Stroke and Death; TIA=transient ischemic attack.

References
  1. Johnston SC, Amarenco P, Denison H, et al; for the THALES Investigators. Ticagrelor and aspirin or aspirin alone in acute ischemic stroke or TIA. N Engl J Med. 2020;383(3):207-217 and Supplementary Appendix.
  2. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021.