Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2) - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00111852

Purpose

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.

Condition	Intervention	Phase
Stroke, Acute	Drug: Desmoteplase	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single Bolus, Multinational, Multi-Center, Parallel Group, Dose-Ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke

Resource links provided by NLM:

Drug Information available for: Desmoteplase

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Clinical improvement at day 90 defined for each patient as achievement of all three of the following criteria
Improvement of greater than or equal to 8 points from baseline on the National Institutes of Health Stroke Scale (NIHSS) (or NIHSS score less than or equal to 1)
Modified Rankin Scale (MRS) score of 0-2
Barthel Index (BI) score of 75-100.

Secondary Outcome Measures:

Include the following
percentage (%) of patients with improvement of greater than or equal to 8 points from baseline on the NIHSS (or NIHSS score less than or equal to 1) at Day 90
percentage (%) of patients with MRS score of 0-2 at day 90
percentage (%) of patients with BI score of 75-100 at Day 90
change from baseline in infarct volume at Day 30.

Estimated Enrollment:	186
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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, arterio-venous 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111852

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Locations

United States, Alabama
Alabama Neurological Institute, Dept. of Neurology
Birmingham, Alabama, United States, 35209
United States, California
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90024-1777
United States, Florida
Brain Matters, Inc.
Delray Beach, Florida, United States, 33445
Melbourne Internal Medicine Associates (MIMA)
Melbourne, Florida, United States, 32901-3182
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Parkview Hospital
Fort Wayne, Indiana, United States, 46805-5410
Indiana Neuroscience Institute
Indianapolis, Indiana, United States, 46260
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Jewish Hospital Healthcare Services, Inc.
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
United States, Nevada
Nevada Neurosciences Institute at Sunrise
Las Vegas, Nevada, United States, 89109
United States, New Jersey
JFK Medical Center
Edison, New Jersey, United States, 08818
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Saint Thomas Hospital
Nashville, Tennessee, United States, 37205
University of Tennessee, College of Medicine
Chattanooga, Tennessee, United States, 37404
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
University of Texas, Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8897
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Winchester Medical Center
Winchester, Virginia, United States, 22601
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Australia
John Hunter Hospital
New Lambton Heights, Australia, NSW 2310
Box Hill Hospital
Victoria, Australia, 3128
Queen Elizabeth Hospital
Woodville, Australia, SA 5011
Austria
Medizinische Universitat Graz
Graz, Austria, 8036
Leopold-Franzens-Universitat Innsbruck
Innsbruck, Austria, 6020
O O Landesnervenklinik Wagner-Jauregg
Linz, Austria, 4020
Canada, Alberta
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z3J5
Finland
Helsinki University Central Hospital
Helsinki, Finland, FIN-00029 HUS
Kuopio University Hospital
Kuopio, Finland, FIN-70211
Germany
Neurologische Universitatsklinik
Bonn, Germany, 53105
Klinik und Poliklinik der Universitat Leipzig
Leipzig, Germany, 04103
Neurologische Klinik Universitat Ulm
Ulm, Germany, 49 (0) 731 500 50986
Netherlands
University Hospital Amsterdam Department Neurology
Amsterdam, Netherlands, 1105 DD
Spain
University Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Universitari Doctor Josep Trueta
Girona, Spain, 17007

Sponsors and Collaborators

Forest Laboratories

More Information

No publications provided

Study ID Numbers:	DSP-MD-01
Study First Received:	May 26, 2005
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00111852 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Desmoteplase
Acute Ischemic Stroke
Stroke, Acute

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents

Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Salivary plasminogen activator alpha 1, Desmodus rotundus

ClinicalTrials.gov processed this record on November 27, 2009