Stroke, Acute
Conditions
Keywords
Desmoteplase, Acute Ischemic Stroke, Stroke, Acute
Brief summary
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.
Interventions
DRUGDesmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.
DRUGPlacebo
Dose-Match Placebo, intravenous administration.
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Eligible for study treatment within 3-9 hours after onset of stroke symptoms. * Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke. Inclusion Criteria from diagnostic imaging screening: * Distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related to middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory in a hemispheric distribution.
Exclusion criteria
* History or clinical presentation of intracranial hemorrhage (ICH), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm. * Rapidly improving neurological symptoms. * Pre-stroke MRS score of \> 1 (including previous disability). * Suspected acute vertebral or basilar artery occlusion. * Current use of anticoagulants and a prolonged prothrombin time. * Uncontrolled hypertension. * Baseline hematocrit of \< 0.25. * Baseline platelet count \< 100,000/mm3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | Change from Baseline to day 90 | 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). |
| Modified Rankin Scale (MRS) | Day 90 | 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). |
| Barthel Index (BI) score of 75-100. | Day 90 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with improvement in NIHSS score | From Baseline to Day 90 | Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1. |
| Infarct Volume | Change from baseline to Day 30 | — |
| Percentage of patients with MRS score of 0-2 | Day 90 | — |
| Percentage of patients with BI score of 75-100 | Day 90 | — |
Countries
Australia, Austria, Canada, Finland, Germany, Netherlands, Spain, United States
Outcome results
None listed