Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
NCT ID: NCT00111852
Last Updated: 2012-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
193 participants
INTERVENTIONAL
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Desmoteplase, low dose
Desmoteplase 90 mcg/kg, intravenous administration.
Desmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.
Desmoteplase, high dose
Desmoteplase 125 mcg/kg, intravenous administration.
Desmoteplase
Desmoteplase 125 mcg/kg, intravenous administration.
Placebo
Dose-Match Placebo, intravenous administration.
Placebo
Dose-Match Placebo, intravenous administration.
Interventions
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Desmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.
Desmoteplase
Desmoteplase 125 mcg/kg, intravenous administration.
Placebo
Dose-Match Placebo, intravenous administration.
Eligibility Criteria
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Inclusion Criteria
* Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke.
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Leslie Lipka, MD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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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
University of Louisville Hospital
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Nevada Neurosciences Institute at Sunrise
Las Vegas, Nevada, United States
JFK Medical Center
Edison, New Jersey, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Erlanger Health System
Chattanooga, Tennessee, United States
University of Tennessee, College of Medicine
Chattanooga, Tennessee, United States
Saint Thomas Hospital
Nashville, Tennessee, United States
University of Texas, Southwestern Medical Center at Dallas
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Winchester Medical Center
Winchester, Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
John Hunter Hospital
New Lambton Heights, , Australia
Box Hill Hospital
Victoria, , Australia
Queen Elizabeth Hospital
Woodville, , Australia
Medizinische Universitat Graz
Graz, , Austria
Leopold-Franzens-Universitat Innsbruck
Innsbruck, , Austria
O O Landesnervenklinik Wagner-Jauregg
Linz, , Austria
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Helsinki University Central Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Neurologische Universitatsklinik
Bonn, , Germany
Klinik und Poliklinik der Universitat Leipzig
Leipzig, , Germany
Neurologische Klinik Universitat Ulm
Ulm, , Germany
University Hospital Amsterdam Department Neurology
Amsterdam, , Netherlands
University Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitari Doctor Josep Trueta
Girona, , Spain
Countries
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References
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Warach S, Al-Rawi Y, Furlan AJ, Fiebach JB, Wintermark M, Lindsten A, Smyej J, Bharucha DB, Pedraza S, Rowley HA. Refinement of the magnetic resonance diffusion-perfusion mismatch concept for thrombolytic patient selection: insights from the desmoteplase in acute stroke trials. Stroke. 2012 Sep;43(9):2313-8. doi: 10.1161/STROKEAHA.111.642348. Epub 2012 Jun 26.
Fiebach JB, Al-Rawi Y, Wintermark M, Furlan AJ, Rowley HA, Lindsten A, Smyej J, Eng P, Warach S, Pedraza S. Vascular occlusion enables selecting acute ischemic stroke patients for treatment with desmoteplase. Stroke. 2012 Jun;43(6):1561-6. doi: 10.1161/STROKEAHA.111.642322. Epub 2012 Apr 3.
Hacke W, Furlan AJ, Al-Rawi Y, Davalos A, Fiebach JB, Gruber F, Kaste M, Lipka LJ, Pedraza S, Ringleb PA, Rowley HA, Schneider D, Schwamm LH, Leal JS, Sohngen M, Teal PA, Wilhelm-Ogunbiyi K, Wintermark M, Warach S. Intravenous desmoteplase in patients with acute ischaemic stroke selected by MRI perfusion-diffusion weighted imaging or perfusion CT (DIAS-2): a prospective, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2009 Feb;8(2):141-50. doi: 10.1016/S1474-4422(08)70267-9. Epub 2008 Dec 25.
Other Identifiers
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DSP-MD-01
Identifier Type: -
Identifier Source: org_study_id
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