View in EDS HTML Full Text PDF Full Text

Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial. GAIN International Investigators.

Saved in:
Bibliographic Details
Title: Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial. GAIN International Investigators.
Authors: Lees, Kennedy R, Asplund, Kjell, Carolei, Antonio, Davis, Stephen M, Diener, Hans-Christoph, Kaste, Markku, Orgogozo, Jean-Marc, Whitehead, John, Lees, K R (AUTHOR), Asplund, K (AUTHOR), Carolei, A (AUTHOR), Davis, S M (AUTHOR), Diener, H C (AUTHOR), Kaste, M (AUTHOR), Orgogozo, J M (AUTHOR), Whitehead, J (AUTHOR)
Source: Lancet. 6/3/2000, Vol. 355 Issue 9219, p1949-1954. 6p. 4 Charts, 3 Graphs.
Subjects: Brain disease treatment, Cerebrovascular disease, Ischemia treatment, Glycine, Clinical medicine research, Therapeutics
Abstract: Background: Early treatment may improve acute ischaemic stroke outcome. Gavestinel is a selective antagonist at the glycine site of the N-methyl-D-aspartate (NMDA) receptor, and is neuroprotective in animal models of ischaemic stroke.Methods: We did a randomised, double-blind, placebo-controlled trial to test whether gavestinel could improve functional outcome after acute stroke in human beings. Conscious patients with stroke involving limb weakness received either gavestinel at an intravenous loading dose of 800 mg followed by 200 mg every 12 h for five doses, or matching placebo, within 6 h of stroke onset. Stratification variables were age and stroke severity. A computed tomography brain scan within 18 h of stroke onset identified the primary efficacy population with ischaemic stroke. Outcome was assessed by an independent observer with the Barthel index at 3 months. Three outcome categories were applied: good (Barthel index 95-100), moderate (60-90), and poor (0-55 or dead). Analysis was by intention to treat.Findings: Of 1804 patients randomised, 16 received no treatment, and 333 had primary intracranial haemorrhage. 891 patients received gavestinel and 897 received placebo. Outcome in 721 patients who received gavestinel and were analysed for the primary endpoint at 3 months was good in 246 (34.1%), moderate in 136 (18.8%), and poor in 339 (47.0%), compared with 256 (34.9%), 133 (18.1%), and 345 (47.0%), respectively, of 734 patients who received placebo (p=0.8). Mortality at 3 months was 147 (20.4%) in the gavestinel group and 138 (18.8%) in the placebo group. Outcomes within preplanned subgroup and secondary analyses were also neutral. There were no significant differences in serious side-effects between the groups.Interpretation: Treatment with gavestinel within 6 h of acute ischaemic stroke did not improve outcome. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 3182858
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial. GAIN International Investigators.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Lees%2C+Kennedy+R%22">Lees, Kennedy R</searchLink><br /><searchLink fieldCode="AR" term="%22Asplund%2C+Kjell%22">Asplund, Kjell</searchLink><br /><searchLink fieldCode="AR" term="%22Carolei%2C+Antonio%22">Carolei, Antonio</searchLink><br /><searchLink fieldCode="AR" term="%22Davis%2C+Stephen+M%22">Davis, Stephen M</searchLink><br /><searchLink fieldCode="AR" term="%22Diener%2C+Hans-Christoph%22">Diener, Hans-Christoph</searchLink><br /><searchLink fieldCode="AR" term="%22Kaste%2C+Markku%22">Kaste, Markku</searchLink><br /><searchLink fieldCode="AR" term="%22Orgogozo%2C+Jean-Marc%22">Orgogozo, Jean-Marc</searchLink><br /><searchLink fieldCode="AR" term="%22Whitehead%2C+John%22">Whitehead, John</searchLink><br /><searchLink fieldCode="AR" term="%22Lees%2C+K+R%22">Lees, K R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Asplund%2C+K%22">Asplund, K</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Carolei%2C+A%22">Carolei, A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Davis%2C+S+M%22">Davis, S M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Diener%2C+H+C%22">Diener, H C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kaste%2C+M%22">Kaste, M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Orgogozo%2C+J+M%22">Orgogozo, J M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Whitehead%2C+J%22">Whitehead, J</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 6/3/2000, Vol. 355 Issue 9219, p1949-1954. 6p. 4 Charts, 3 Graphs.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Brain+disease+treatment%22">Brain disease treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Cerebrovascular+disease%22">Cerebrovascular disease</searchLink><br /><searchLink fieldCode="DE" term="%22Ischemia+treatment%22">Ischemia treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Glycine%22">Glycine</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+medicine+research%22">Clinical medicine research</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: <bold>Background: </bold>Early treatment may improve acute ischaemic stroke outcome. Gavestinel is a selective antagonist at the glycine site of the N-methyl-D-aspartate (NMDA) receptor, and is neuroprotective in animal models of ischaemic stroke.<bold>Methods: </bold>We did a randomised, double-blind, placebo-controlled trial to test whether gavestinel could improve functional outcome after acute stroke in human beings. Conscious patients with stroke involving limb weakness received either gavestinel at an intravenous loading dose of 800 mg followed by 200 mg every 12 h for five doses, or matching placebo, within 6 h of stroke onset. Stratification variables were age and stroke severity. A computed tomography brain scan within 18 h of stroke onset identified the primary efficacy population with ischaemic stroke. Outcome was assessed by an independent observer with the Barthel index at 3 months. Three outcome categories were applied: good (Barthel index 95-100), moderate (60-90), and poor (0-55 or dead). Analysis was by intention to treat.<bold>Findings: </bold>Of 1804 patients randomised, 16 received no treatment, and 333 had primary intracranial haemorrhage. 891 patients received gavestinel and 897 received placebo. Outcome in 721 patients who received gavestinel and were analysed for the primary endpoint at 3 months was good in 246 (34.1%), moderate in 136 (18.8%), and poor in 339 (47.0%), compared with 256 (34.9%), 133 (18.1%), and 345 (47.0%), respectively, of 734 patients who received placebo (p=0.8). Mortality at 3 months was 147 (20.4%) in the gavestinel group and 138 (18.8%) in the placebo group. Outcomes within preplanned subgroup and secondary analyses were also neutral. There were no significant differences in serious side-effects between the groups.<bold>Interpretation: </bold>Treatment with gavestinel within 6 h of acute ischaemic stroke did not improve outcome. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=3182858
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/S0140-6736(00)02326-6
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 6
        StartPage: 1949
    Subjects:
      – SubjectFull: Brain disease treatment
        Type: general
      – SubjectFull: Cerebrovascular disease
        Type: general
      – SubjectFull: Ischemia treatment
        Type: general
      – SubjectFull: Glycine
        Type: general
      – SubjectFull: Clinical medicine research
        Type: general
      – SubjectFull: Therapeutics
        Type: general
    Titles:
      – TitleFull: Glycine antagonist (gavestinel) in neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial. GAIN International Investigators.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Lees, Kennedy R
      – PersonEntity:
          Name:
            NameFull: Asplund, Kjell
      – PersonEntity:
          Name:
            NameFull: Carolei, Antonio
      – PersonEntity:
          Name:
            NameFull: Davis, Stephen M
      – PersonEntity:
          Name:
            NameFull: Diener, Hans-Christoph
      – PersonEntity:
          Name:
            NameFull: Kaste, Markku
      – PersonEntity:
          Name:
            NameFull: Orgogozo, Jean-Marc
      – PersonEntity:
          Name:
            NameFull: Whitehead, John
      – PersonEntity:
          Name:
            NameFull: Lees, K R
      – PersonEntity:
          Name:
            NameFull: Asplund, K
      – PersonEntity:
          Name:
            NameFull: Carolei, A
      – PersonEntity:
          Name:
            NameFull: Davis, S M
      – PersonEntity:
          Name:
            NameFull: Diener, H C
      – PersonEntity:
          Name:
            NameFull: Kaste, M
      – PersonEntity:
          Name:
            NameFull: Orgogozo, J M
      – PersonEntity:
          Name:
            NameFull: Whitehead, J
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 03
              M: 06
              Text: 6/3/2000
              Type: published
              Y: 2000
          Identifiers:
            – Type: issn-print
              Value: 01406736
          Numbering:
            – Type: volume
              Value: 355
            – Type: issue
              Value: 9219
          Titles:
            – TitleFull: Lancet
              Type: main
ResultId 1