Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
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
1 other identifier
interventional
193
7 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 26, 2005
CompletedFirst Posted
Study publicly available on registry
May 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedMarch 20, 2012
March 1, 2012
1.9 years
May 26, 2005
March 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
National Institutes of Health Stroke Scale (NIHSS)
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).
Change from Baseline to day 90
Modified Rankin Scale (MRS)
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).
Day 90
Barthel Index (BI) score of 75-100.
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)
Day 90
Secondary Outcomes (4)
Percentage of patients with improvement in NIHSS score
From Baseline to Day 90
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
Study Arms (3)
Desmoteplase, low dose
EXPERIMENTALDesmoteplase 90 mcg/kg, intravenous administration.
Desmoteplase, high dose
EXPERIMENTALDesmoteplase 125 mcg/kg, intravenous administration.
Placebo
PLACEBO COMPARATORDose-Match Placebo, intravenous administration.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Alabama Neurological Institute, Dept. of Neurology
Birmingham, Alabama, 35209, United States
University of California Los Angeles Medical Center
Los Angeles, California, 90024-1777, United States
Brain Matters, Inc.
Delray Beach, Florida, 33445, United States
Melbourne Internal Medicine Associates (MIMA)
Melbourne, Florida, 32901-3182, United States
Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Parkview Hospital
Fort Wayne, Indiana, 46805-5410, United States
Indiana Neuroscience Institute
Indianapolis, Indiana, 46260, United States
Jewish Hospital Healthcare Services, Inc.
Louisville, Kentucky, 40202, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215, United States
Nevada Neurosciences Institute at Sunrise
Las Vegas, Nevada, 89109, United States
JFK Medical Center
Edison, New Jersey, 08818, United States
Presbyterian Hospital
Charlotte, North Carolina, 28233-3549, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
University of Tennessee, College of Medicine
Chattanooga, Tennessee, 37404, United States
Saint Thomas Hospital
Nashville, Tennessee, 37205, United States
University of Texas, Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8897, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
John Hunter Hospital
New Lambton Heights, NSW 2310, Australia
Box Hill Hospital
Victoria, 3128, Australia
Queen Elizabeth Hospital
Woodville, SA 5011, Australia
Medizinische Universitat Graz
Graz, 8036, Austria
Leopold-Franzens-Universitat Innsbruck
Innsbruck, 6020, Austria
O O Landesnervenklinik Wagner-Jauregg
Linz, 4020, Austria
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z3J5, Canada
Helsinki University Central Hospital
Helsinki, FIN-00029 HUS, Finland
Kuopio University Hospital
Kuopio, FIN-70211, Finland
Neurologische Universitatsklinik
Bonn, 53105, Germany
Klinik und Poliklinik der Universitat Leipzig
Leipzig, 04103, Germany
Neurologische Klinik Universitat Ulm
Ulm, 49 (0) 731 500 50986, Germany
University Hospital Amsterdam Department Neurology
Amsterdam, 1105 DD, Netherlands
University Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Doctor Josep Trueta
Girona, 17007, Spain
Related Publications (3)
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.
PMID: 22738918DERIVEDFiebach 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.
PMID: 22474060DERIVEDHacke 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.
PMID: 19097942DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Leslie Lipka, MD
Forest Laboratories
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2005
First Posted
May 27, 2005
Study Start
April 1, 2005
Primary Completion
March 1, 2007
Last Updated
March 20, 2012
Record last verified: 2012-03