CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
Alteplase +1 moredrug
Likely dose
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/NCT01525290
NCT01525290Phase 3Completed
CompareCT.gov

Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke: a Randomised, Double-blind, Placebo-controlled Trial

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Feb 2, 2012·Updated Oct 11, 2018

In Brief

A Phase 3 clinical trial evaluating Alteplase and Placebo for Stroke. Completed, enrolled 501 participants across 7 sites in 6 countries.

Detailed Summary

WAKE-UP is an investigator initiated European multicenter randomized controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown symptom onset.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesBelgium, Denmark, France, Germany, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2012
Enrollment StartSep 1, 2012
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 14.4 years ago

Interventions

Alteplasedrug

Intravenous tissue plasminogen activator (Alteplase) 0.9 mg/kg body-weight up to a maximum of 90 mg, 10% as bolus, 90% over 1 hour as infusion

Placebodrug

lyophilised powder to be reconstituted as solution indistinguishable from the active drug