The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
193
Desmoteplase 90 mcg/kg, intravenous administration.
Desmoteplase 125 mcg/kg, intravenous administration.
Dose-Match Placebo, intravenous administration.
National Institutes of Health Stroke Scale (NIHSS)
Improvement of greater than or equal to 8 points from baseline, or NIHSS score less than or equal to 1. The NIHSS score ranges from 0 (least severe) to 42 (more severe).
Time frame: Change from Baseline to day 90
Modified Rankin Scale (MRS)
Improvement on the Modified Rankin Scale, defined as a score of 0-2. The MRS ranges in severity from 0 (no symptoms) to 6 (Dead).
Time frame: Day 90
Barthel Index (BI) score of 75-100.
The Barthel Index (BI) is a scale used to measure performance in basic Activities of Daily Livingranges from 0 (most disablility) to 100 (no disability)
Time frame: Day 90
Percentage of patients with improvement in NIHSS score
Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1.
Time frame: From Baseline to Day 90
Percentage of patients with MRS score of 0-2
Time frame: Day 90
Percentage of patients with BI score of 75-100
Time frame: Day 90
Infarct Volume
Time frame: Change from baseline to Day 30
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Alabama Neurological Institute, Dept. of Neurology
Birmingham, Alabama, United States
University of California Los Angeles Medical Center
Los Angeles, California, United States
Brain Matters, Inc.
Delray Beach, Florida, United States
Melbourne Internal Medicine Associates (MIMA)
Melbourne, Florida, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
Parkview Hospital
Fort Wayne, Indiana, United States
Indiana Neuroscience Institute
Indianapolis, Indiana, United States
Jewish Hospital Healthcare Services, Inc.
Louisville, Kentucky, United States
...and 34 more locations