Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 10, 2007

Last Updated Date

October 1, 2007

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. [ Time Frame: 24 hours ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00472381 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Modified Rankin Scale at three months [ Time Frame: three months ]
Magnetic resonance imaging (MRI) infarct growth at one day [ Time Frame: one day ]
Percentage of patients with hypoglycaemic event (< 3 mmol/l)

Original Secondary Outcome Measures ^†

Modified Rankin Scale at three months [ Time Frame: three months ]
MRI Infarct Growth at one day Percentage of patients with hypoglycaemic event (< 3 mmol/l) [ Time Frame: one day ]

Descriptive Information

Brief Title ^†

Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke

Official Title ^†

Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

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.

Detailed Description

It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours < 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Acute Stroke
Acute Cerebral Ischemia

Intervention ^†

Drug: Insulin

Study Arms / Comparison Groups

Publications *

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. Review. French.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

180

Estimated Completion Date

September 2009

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Yves Samson, MD,PhD

+33(0) 1 42 16 18 54

yves.samson@psl.aphp.fr

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00472381

Responsible Party

Secondary IDs ^††

SCR06011

Study Sponsor ^†

Assistance Publique - Hôpitaux de Paris

Collaborators ^††

CNRS UPR 640 LENA
Clinical Research Unit

Investigators ^†

Principal Investigator:

Yves Samson, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.