NCT00472381

Brief Summary

Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 5, 2014

Status Verified

September 1, 2012

Enrollment Period

5.1 years

First QC Date

May 10, 2007

Last Update Submit

June 4, 2014

Conditions

Acute StrokeAcute Cerebral Ischemia

Keywords

Acute Ischemic StrokePost-Stroke HyperglycaemiaInsulin treatmentInsulinDWIMRI

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.

    24 hours

Secondary Outcomes (3)

  • Modified Rankin Scale at three months

    three months

  • Magnetic resonance imaging (MRI) infarct growth at one day

    one day

  • Percentage of patients with hypoglycaemic event (< 3 mmol/l)

    during the study

Study Arms (1)

2

EXPERIMENTAL

Insulin

Drug: Insulin

Interventions

InsulinDRUG

Insulin

2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Carotid territory stroke
  • MRI performed in the first five hours of stroke onset
  • Baseline National Institutes of Health Stroke Scale (NIHSS) \> 4 or \< 26
  • Time between MRI and treatment under one hour

You may not qualify if:

  • Pre-existing Modified Rankin Scale of three or higher
  • Advanced or terminal illness with risk of death in the next 6 months, addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Urgences cerebro vasculaires La Pitié Salpétrière

Poissy, 75013, France

Location

Related Publications (3)

  • Samson Y, Bruandet M, Lejeune M, Deltour S, Grimaldi A. [Insulin in the treatment of ischemic stroke]. Presse Med. 2006 Apr;35(4 Pt 2):696-8. doi: 10.1016/s0755-4982(06)74664-4. French.

    PMID: 16614616RESULT

  • Rosso C, Pires C, Corvol JC, Baronnet F, Crozier S, Leger A, Deltour S, Valabregue R, Amor-Sahli M, Lehericy S, Dormont D, Samson Y. Hyperglycaemia, insulin therapy and critical penumbral regions for prognosis in acute stroke: further insights from the INSULINFARCT trial. PLoS One. 2015 Mar 20;10(3):e0120230. doi: 10.1371/journal.pone.0120230. eCollection 2015.

    PMID: 25793765DERIVED

  • Rosso C, Corvol JC, Pires C, Crozier S, Attal Y, Jacqueminet S, Deltour S, Multlu G, Leger A, Meresse I, Payan C, Dormont D, Samson Y. Intensive versus subcutaneous insulin in patients with hyperacute stroke: results from the randomized INSULINFARCT trial. Stroke. 2012 Sep;43(9):2343-9. doi: 10.1161/STROKEAHA.112.657122. Epub 2012 Jun 14.

    PMID: 22700528DERIVED

Related Links

MeSH Terms

Conditions

StrokeIschemic StrokeInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Yves Samson, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 5, 2014

Record last verified: 2012-09

Locations

FR(1)