A Phase 3 interventional study of Alteplase and Placebo in Stroke, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 7 sites in 6 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 3, Interventional, and Treatment
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.
WAKE-UP is a 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. Intravenous thrombolysis with Alteplase is available as effective and safe treatment of acute stroke within 4.5 hours of symptom onset. However, in about 20% of acute stroke patients time of symptom onset is unknown. This large group of patients is currently excluded from treatment with Alteplase. The objective of the research proposed in the WAKE-UP project is to provide effective treatment options for this large group of acute stroke patients.
WAKE-UP is designed 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. Patients will be enrolled based on MRI findings indicative of acute ischemic stroke less than 4.5 hours of age.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 501 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.
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Clinical Inclusion Criteria
Imaging Inclusion Criteria:
Exclusion Criteria:
Clinical Exclusion Criteria
Imaging Exclusion Criteria:
Intervention drug: intravenous tissue plasminogen activator (tPA), alteplase
Drug: Alteplase
Intervention drug: placebo
Drug: Placebo
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
Also known as: Actilyse, Activase, rt-PA
lyophilised powder to be reconstituted as solution indistinguishable from the active drug
Efficacy
Favourable outcome (Modified Rankin Scale 0-1)
Time frame: 90 day after stroke
Safety
* Mortality * Death or dependency (Modified Rankin Scale 4-6)
Time frame: 90 day after stroke
Efficacy
* Global outcome score * Responder analysis (Modified Rankin Scale 0, 0-1 or 0-2 depending on severity of symptoms assessed by the National Institutes of Health Stroke Scale on admission) * Outcome across all disability ranges (categorical shift in Modified Rankin Scale score) * Infarct volume (measured 22-36 hours after treatment) * Functional health status and quality of life * Use of health care system resources
Time frame: 90 days after stroke
Safety
* Symptomatic intracranial haemorrhage (SICH) as defined in SITS-MOST * SICH as defined ECASS II * SICH as defined in NINDS * Parenchymal haemorrhage type 2 (PH-2)
Time frame: 90 days after stroke
Ran from Sep 2012 to primary completion in Oct 2018, 73 months.
Of 124 non-industry phase 3 interventional studies under Stroke, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 68. This study's 73 months is above that.
Counting every sponsor, half of 157 studies reached it within 36 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tissue Plasminogen Activator
Universitätsklinikum Hamburg-Eppendorf →