Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
- Registration Number
- NCT00111852
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 193
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Dose-Match Placebo, intravenous administration. Desmoteplase, low dose Desmoteplase Desmoteplase 90 mcg/kg, intravenous administration. Desmoteplase, high dose Desmoteplase Desmoteplase 125 mcg/kg, intravenous administration.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Percentage of patients with MRS score of 0-2 Day 90 Percentage of patients with BI score of 75-100 Day 90 Infarct Volume Change from baseline to Day 30
Trial Locations
- Locations (44)
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Melbourne Internal Medicine Associates (MIMA)
🇺🇸Melbourne, Florida, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
Brain Matters, Inc.
🇺🇸Delray Beach, Florida, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Texas, Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Nevada Neurosciences Institute at Sunrise
🇺🇸Las Vegas, Nevada, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
Saint Thomas Hospital
🇺🇸Nashville, Tennessee, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
Walter Mackenzie Health Sciences Centre
🇨🇦Edmonton, Alberta, Canada
Leopold-Franzens-Universitat Innsbruck
🇦🇹Innsbruck, Austria
Queen Elizabeth Hospital
🇦🇺Woodville, Australia
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Klinik und Poliklinik der Universitat Leipzig
🇩🇪Leipzig, Germany
Kuopio University Hospital
🇫🇮Kuopio, Finland
Alabama Neurological Institute, Dept. of Neurology
🇺🇸Birmingham, Alabama, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of California Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Jewish Hospital Healthcare Services, Inc.
🇺🇸Louisville, Kentucky, United States
Indiana Neuroscience Institute
🇺🇸Indianapolis, Indiana, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
JFK Medical Center
🇺🇸Edison, New Jersey, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
University of Tennessee, College of Medicine
🇺🇸Chattanooga, Tennessee, United States
John Hunter Hospital
🇦🇺New Lambton Heights, Australia
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Winchester Medical Center
🇺🇸Winchester, Virginia, United States
Box Hill Hospital
🇦🇺Victoria, Australia
Medizinische Universitat Graz
🇦🇹Graz, Austria
O O Landesnervenklinik Wagner-Jauregg
🇦🇹Linz, Austria
Neurologische Klinik Universitat Ulm
🇩🇪Ulm, Germany
Neurologische Universitatsklinik
🇩🇪Bonn, Germany
University Hospital Amsterdam Department Neurology
🇳🇱Amsterdam, Netherlands
University Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitari Doctor Josep Trueta
🇪🇸Girona, Spain