Status:
COMPLETED
Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
Lead Sponsor:
Forest Laboratories
Conditions:
Stroke, Acute
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT00111852
Start Date
April 1 2005
Last Update
March 20 2012
Active Locations (44)
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1
Alabama Neurological Institute, Dept. of Neurology
Birmingham, Alabama, United States, 35209
2
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90024-1777
3
Brain Matters, Inc.
Delray Beach, Florida, United States, 33445
4
Melbourne Internal Medicine Associates (MIMA)
Melbourne, Florida, United States, 32901-3182