MedTrace Logo

Extending the Time for Thrombolysis in Emergency Neurological Deficits

NCT00887328 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-08-31

No results posted yet for this study

Summary

The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.

Conditions

Interventions

DRUG

Tissue Plasminogen Activator (Alteplase)

0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour

DRUG

Placebo

placebo provided as 50mg lyophilised powder to be reconstituted with sterile water in glass vials indistinguishable from active drug

Sponsors & Collaborators

  • Commonwealth Scientific and Industrial Research Organisation, Australia

    collaborator OTHER_GOV

  • University of Melbourne

    collaborator OTHER

  • Melbourne Health

    collaborator OTHER

  • The Florey Institute of Neuroscience and Mental Health

    collaborator OTHER

  • Neuroscience Trials Australia

    lead OTHER

Principal Investigators

  • Geoffrey Donnan, MD FRACP · The Florey Institute of Neuroscence and Mental Health

  • Stephen Davis, MD FRACP · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2018-08-27
Completion
2018-08-27

Countries

  • Australia
  • Finland
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887328 on ClinicalTrials.gov