Status:
COMPLETED
IV vs. IA tPA (Activase) in Acute Ischemic Stroke With CTA Evidence of Major Vessel Occlusion
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Ischemic Stroke
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Stroke is the third leading cause of death in the United States, responsible for 158,488 deaths in 1998 (American Heart Association). Nationwide, each year, an estimated 600,000 to 750,000 people suff...
Detailed Description
DESCRIPTION OF THE STUDY This is a randomized, controlled, single center feasibility and preliminary safety study to determine the clinical efficacy of Activase administered locally, IA, in the course...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age \> 18 years
- NIHSS ≥ 4 or isolated aphasia or isolated hemianopsia
Exclusion
- NIHSS \>30
- Coma
- Rapidly improving symptoms
- History of stroke in the last 6 weeks
- Seizure at onset
- Subarachnoid Hemorrhage (SAH ) or suspected SAH
- Any history of Intracrannial Hemorrhage (ICH)
- Neoplasm
- Septic embolism
- Surgery, biopsy, trauma or LP in last 30 days
- Head trauma in the last 90 days
- Bleeding diathesis, or INR \>1.7 or PTT \>1.5 times baseline or platelet \<100K
- SBP \>180 or DBP ≥100 despite treatment with 3 doses of IV Labetalol (10-20 mg Q10")
- Lacunar stroke syndrome
- CT: Hemorrhage, tumor (except small meningioma), significant mass effect, midline shift, acute hypodensity or \>1/3 MCA territory sulcal effacement
- Radiological contrast hypersensitivity
- Angiographic: Dissection, lack of access, lack of occlusion, or nonatherosclerotic arteriopathy
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00624000
Start Date
March 1 2004
End Date
December 1 2008
Last Update
November 8 2011
Active Locations (1)
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1
University of North Carolina Stroke Center
Chapel Hill, North Carolina, United States, 27599-7025