Rationale and design of combination of an immune modulator Fingolimod with Alteplase bridging with Mechanical Thrombectomy in Acute Ischemic Stroke (FAMTAIS) trial

Research output: Contribution to journalReview article

Authors

  • Sheng Zhang
  • Ying Zhou
  • Ruiting Zhang
  • Meixia Zhang
  • Bruce Campbell
  • Longting Lin
  • Fu Dong Shi
  • Min Lou

External Institution(s)

  • 2nd Affiliated Hospital of Zhejiang University
  • Royal Melbourne Hospital
  • University of Newcastle

Details

Original languageEnglish (US)
Pages (from-to)906-909
Number of pages4
JournalInternational Journal of Stroke
Volume12
Issue number8
StatusPublished - Oct 1 2017
Peer-reviewedYes

Abstract

Rationale: In acute ischemic stroke patients with large vessel occlusion, although reperfusion within 6 h after stroke onset using combined intravenous alteplase and mechanical thrombectomy (bridging therapy) can improve functional outcome, still approximately 50% patients suffer disability which may result from reperfusion injury. Proof-of-concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in acute ischemic stroke patients as a single therapy beyond 4.5 h of disease onset, or in combination with alteplase within 4.5 h of disease onset. Aim: To assess whether the treatment of fingolimod combined with bridging therapy in large vessel occlusion acute ischemic stroke patients is effective and safe. Design and sample size estimates: Fingolimod with Alteplase bridging with Mechanical Thrombectomy in Acute Ischemic Stroke (FAMTAIS) study is a randomized, open-label, multiple central trial. This study includes 98 patients with anterior circulation large vessel occlusion acute ischemic stroke who are eligible for bridging therapy, providing 80% power to reject the null hypothesis that, combined with fingolimod, the bridging therapy has an at least 15% higher penumbra tissue salvage index than receiving bridging therapy alone. Study outcomes: The primary outcome is the penumbra tissue salvage index. Key secondary outcomes focus on: infarct growth and extent of clinical improvement from day 1 to day 7, frequency of parenchymal hemorrhage at day 1. Discussion: If the hypothesis of FAMTAIS is confirmed, combination of fingolimod with bridging therapy is effective in attenuating reperfusion injury in patients with large vessel occlusion treated with 6 h of stroke onset.

    Research areas

  • Brain ischemia, bridging therapy, inflammation, penumbra salvage, reperfusion injury

Citation formats

APA

Zhang, S., Zhou, Y., Zhang, R., Zhang, M., Campbell, B., Lin, L., ... Lou, M. (2017). Rationale and design of combination of an immune modulator Fingolimod with Alteplase bridging with Mechanical Thrombectomy in Acute Ischemic Stroke (FAMTAIS) trial. International Journal of Stroke, 12(8), 906-909. https://doi.org/10.1177/1747493017710340

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