Trials / Completed
CompletedNCT01580839
EXTEND (International): Extending the Time for Thrombolysis in Emergency Neurological Deficits (International)
Extending the Time for Thrombolysis in Emergency Neurological Deficits
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Neuroscience Trials Australia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (according to imaging criteria) at 4.5 (or 3 hours depending on local guidelines) - 9 hours post onset of stroke or after 'wake up stroke' (WUS) will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2012-12-06
- Primary completion
- 2018-08-22
- Completion
- 2018-08-22
- First posted
- 2012-04-19
- Last updated
- 2018-08-31
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01580839. Inclusion in this directory is not an endorsement.