Safety of Intravenous Thrombolysis for Wake-up Stroke (Wake-Up Stroke)
The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV t-PA) in ischemic stroke patients who present to the emergency department (ED) after awakening with the symptoms of suspected ischemic stroke.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety of Intravenous Thrombolysis for Wake-up Stroke|
- Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.
- 90-day Modified Rankin Scale (mRS) Score 0 or 1 [ Time Frame: 90 days ] [ Designated as safety issue: No ]Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention.
- Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: off label rt-PA used
off label rt-PA used on all subject enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Drug: Alteplase (iv t-PA)
0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.
This is an open label, multi-center, safety study of acute treatment with IV alteplase in ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Clinical improvement defined as a decrease in the National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, 3 days and 90 days and modified Rankin Scale (mRS) score at 3 and 90 days. For patients that have computed tomographic angiogram (CTA) and computed tomographic perfusion (CTP), the incidence of large vessel occlusion will be quantified.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183533
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Colorado|
|Swedish Medical Center|
|Englewood, Colorado, United States, 80113|
|United States, Texas|
|UT-Houston Health Science Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sean I Savitz, MD||UT-Houston Health Science Center|
|Principal Investigator:||Andrew D Barreto, MD||Study Co-PI|