Ischemic Stroke
Conditions
Keywords
Wake-Up Stroke, Ischemic stroke, ischemic stroke patients who wake-up with their symptoms
Brief summary
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.
Detailed description
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.
Interventions
DRUGAlteplase (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.
Sponsors
Genentech, Inc.
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well. * 18 to 80 years old * NIHSS (National Institutes of Health Stroke Scale) ≤25 * Blood Pressure ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment * IV t-PA must be given within 3 hours of awakening from sleep * Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment
Exclusion criteria
* CT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day Modified Rankin Scale (mRS) Score 0 or 1 | 90 days | 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 | 90 days | — |
Countries
United States
Participant flow
Recruitment details
Study was open for enrollment (began recruiting and screening for eligible patients) on July 13, 2010. The date of first enrollment was October 5, 2010 and the date of last enrollment was October 5, 2013. All patients were enrolled at one of five participating centers.
Participants by arm
| Arm | Count |
|---|---|
| Off Label Rt-PA Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Off Label Rt-PA |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 13.2 |
| National Institutes of Health Stroke Scale score, median (range) | 6.5 units on a scale |
| Race/Ethnicity, Customized African American | 16 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian, Hispanic | 6 participants |
| Race/Ethnicity, Customized Caucasian, Non-Hispanic | 17 participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 40 |
| serious Total, serious adverse events | 6 / 40 |
Outcome results
Primary
Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients
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.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off Label Rt-PA | Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients | 0 cases. |
Secondary
90-day Modified Rankin Scale (mRS) Score 0 or 1
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.
Time frame: 90 days
Population: \^ Note: 2 patients were not available for 90-day follow-up assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off Label Rt-PA | 90-day Modified Rankin Scale (mRS) Score 0 or 1 | 20 participants |
Secondary
Mortality
Time frame: 90 days
Population: Note: although 2 patients were not available for complete day 90 assessments, family/patient communication provided necessary mortality information.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off Label Rt-PA | Mortality | 2 participants |