CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 180 enrolled
Drug / intervention
Tissue Plasminogen Activator (Alteplase) +1 moredrug
Likely dose
Tissue Plasminogen Activator (Alteplase) 0.9 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00887328
NCT00887328Phase 3Completed
CompareCT.gov

Extending the Time for Thrombolysis in Emergency Neurological Deficits

Neuroscience Trials Australia·interventional·Posted Apr 23, 2009·Updated Aug 31, 2018

In Brief

A Phase 3 clinical trial evaluating Tissue Plasminogen Activator (Alteplase) and Placebo for Stroke. Completed, enrolled 180 participants across 22 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesAustralia, Finland, New Zealand
CollaboratorsCommonwealth Scientific and Industrial Research Organisation, Australia, University of Melbourne, Melbourne Health, The Florey Institute of Neuroscience and Mental Health

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2009
Enrollment StartJun 1, 2010
Primary CompletionAug 27, 2018
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 17.2 years ago

Interventions

Tissue Plasminogen Activator (Alteplase)drug

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

Placebodrug

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