Status:
COMPLETED
Safety of Intravenous Thrombolysis for Wake-up Stroke
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 symptom...
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 o...
Eligibility Criteria
Inclusion
- 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
- CT
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01183533
Start Date
July 1 2010
End Date
January 1 2014
Last Update
November 25 2014
Active Locations (3)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Swedish Medical Center
Englewood, Colorado, United States, 80113
3
UT-Houston Health Science Center
Houston, Texas, United States, 77030