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.
- Desmoteplase Drug
Intervention Desc: Desmoteplase 125 mcg/kg, intravenous administration. ARM 1: Kind: Experimental Label: Desmoteplase, low dose Description: Desmoteplase 90 mcg/kg, intravenous administration. ARM 2: Kind: Experimental Label: Desmoteplase, high dose Description: Desmoteplase 125 mcg/kg, intravenous administration.
- Placebo Biological
Intervention Desc: Dose-Match Placebo, intravenous administration. ARM 1: Kind: Experimental Label: Placebo Description: Dose-Match Placebo, intravenous administration.
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomized to receive either placebo, or one of two doses of desmoteplase (90 µ/kg or 125 µ/kg).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Primary Efficacy: Clinical improvement at day 90 measured by NIHSS, BI and mRS, and infarct volume (as measured by MRI).|
|Secondary||Change from baseline infarct volume at day 30 (measured by MRI or perfusion CT).|
|Primary||National Institutes of Health Stroke Scale (NIHSS)||Change from Baseline to day 90||No|
|Primary||Modified Rankin Scale (MRS)||Day 90||No|
|Primary||Barthel Index (BI) score of 75-100.||Day 90||No|
|Secondary||Percentage of patients with improvement in NIHSS score||From Baseline to Day 90||No|
|Secondary||Percentage of patients with MRS score of 0-2||Day 90||No|
|Secondary||Percentage of patients with BI score of 75-100||Day 90||No|
|Secondary||Infarct Volume||Change from baseline to Day 30||No|
- Forest Laboratories Lead