Granulocyte Colony–Stimulating Factor in Patients With Acute Ischemic Stroke

DOI Web Site 被引用文献6件
  • E. Bernd Ringelstein
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Vincent Thijs
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Bo Norrving
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Angel Chamorro
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Franz Aichner
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Martin Grond
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Jeff Saver
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Rico Laage
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Armin Schneider
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Frank Rathgeb
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Gerhard Vogt
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Gabriele Charissé
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Jochen B. Fiebach
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Stefan Schwab
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Wolf R. Schäbitz
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Rainer Kollmar
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Marc Fisher
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Miroslav Brozman
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • David Skoloudik
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Franz Gruber
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Joaquin Serena Leal
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Roland Veltkamp
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Martin Köhrmann
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Jörg Berrouschot
    From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.); Department of Neurology, University of Leuven, Leuven, Belgium (V.T.); Vesalius Research Center, VIB, Leuven, Belgium (V.T.); Department of Clinical Sciences, Section of Neurology, Lund University, Lund, Sweden (B.N.); Department of Neurology, University of Barcelona, Barcelona, Spain (A.C.); Department of Neurology, Nervenklinik Wagner-Jauregg, Linz, Austria (F.A.); Department of Neurology, Kreiskrankenhaus Siegen,...
  • Gerlinde Egerer
  • Gerd Mikus
  • Volker Limmroth
  • Meinhard Kieser
  • Luc Bracoud
  • Marc Hermier
  • Juliette Bouffard
  • Rüdiger Weber

書誌事項

タイトル別名
  • Results of the AX200 for Ischemic Stroke Trial

抄録

<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>Granulocyte colony–stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose–escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p> G-CSF (135 µg/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="www.clinicaltrial.gov">www.clinicaltrial.gov</jats:ext-link> ). Main inclusion criteria were ≤9-hour time window after stroke onset, infarct localization in the middle cerebral artery territory, baseline National Institutes of Health Stroke Scale score range of 6 to 22, and baseline diffusion-weighted imaging lesion size ≥15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90, respectively. Data were analyzed using a prespecified model that adjusted for age, National Institutes of Health Stroke Scale score at baseline, and initial infarct volume (diffusion-weighted imaging). </jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p>G-CSF treatment failed to meet the primary and secondary end points of the trial. For additional end points such as mortality, Barthel index, or infarct size at day 30, G-CSF did not show efficacy either. There was, however, a trend for reduced infarct growth in the G-CSF group. G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles, with a strong increase in leukocytes and monocytes. In parallel, the cytokine profile showed a significant decrease of interleukin-1.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>G-CSF, a novel and promising drug candidate with a comprehensive preclinical and clinical package, did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00927836. </jats:p> </jats:sec>

収録刊行物

  • Stroke

    Stroke 44 (10), 2681-2687, 2013-10

    Ovid Technologies (Wolters Kluwer Health)

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