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

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Desmoteplase
Desmoteplase
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Desmoteplase, Acute Ischemic Stroke, Stroke, Acute

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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.

Sites / Locations

  • Alabama Neurological Institute, Dept. of Neurology
  • University of California Los Angeles Medical Center
  • Brain Matters, Inc.
  • Melbourne Internal Medicine Associates (MIMA)
  • Holmes Regional Medical Center
  • Tampa General Hospital
  • Loyola University Medical Center
  • Parkview Hospital
  • Indiana Neuroscience Institute
  • Jewish Hospital Healthcare Services, Inc.
  • University of Louisville Hospital
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Boston University Medical Center
  • Beth Israel Deaconess Medical Center (BIDMC)
  • Nevada Neurosciences Institute at Sunrise
  • JFK Medical Center
  • Presbyterian Hospital
  • The Cleveland Clinic Foundation
  • The Ohio State University Medical Center
  • Erlanger Health System
  • University of Tennessee, College of Medicine
  • Saint Thomas Hospital
  • University of Texas, Southwestern Medical Center at Dallas
  • The Methodist Hospital
  • University of Utah Medical Center
  • Winchester Medical Center
  • University of Wisconsin Hospital and Clinics
  • John Hunter Hospital
  • Box Hill Hospital
  • Queen Elizabeth Hospital
  • Medizinische Universitat Graz
  • Leopold-Franzens-Universitat Innsbruck
  • O O Landesnervenklinik Wagner-Jauregg
  • Walter Mackenzie Health Sciences Centre
  • Vancouver General Hospital
  • Helsinki University Central Hospital
  • Kuopio University Hospital
  • Neurologische Universitatsklinik
  • Klinik und Poliklinik der Universitat Leipzig
  • Neurologische Klinik Universitat Ulm
  • University Hospital Amsterdam Department Neurology
  • University Hospital Germans Trias i Pujol
  • Hospital Universitari Doctor Josep Trueta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Desmoteplase, low dose

Desmoteplase, high dose

Placebo

Arm Description

Desmoteplase 90 mcg/kg, intravenous administration.

Desmoteplase 125 mcg/kg, intravenous administration.

Dose-Match Placebo, intravenous administration.

Outcomes

Primary Outcome Measures

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).
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).
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)

Secondary Outcome Measures

Percentage of patients with improvement in NIHSS score
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
Percentage of patients with BI score of 75-100
Infarct Volume

Full Information

First Posted
May 26, 2005
Last Updated
March 19, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00111852
Brief Title
Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Desmoteplase, Acute Ischemic Stroke, Stroke, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmoteplase, low dose
Arm Type
Experimental
Arm Description
Desmoteplase 90 mcg/kg, intravenous administration.
Arm Title
Desmoteplase, high dose
Arm Type
Experimental
Arm Description
Desmoteplase 125 mcg/kg, intravenous administration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose-Match Placebo, intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Desmoteplase
Intervention Description
Desmoteplase 90 mcg/kg, intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Desmoteplase
Intervention Description
Desmoteplase 125 mcg/kg, intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-Match Placebo, intravenous administration.
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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).
Time Frame
Change from Baseline to day 90
Title
Modified Rankin Scale (MRS)
Description
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).
Time Frame
Day 90
Title
Barthel Index (BI) score of 75-100.
Description
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)
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Percentage of patients with improvement in NIHSS score
Description
Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1.
Time Frame
From Baseline to Day 90
Title
Percentage of patients with MRS score of 0-2
Time Frame
Day 90
Title
Percentage of patients with BI score of 75-100
Time Frame
Day 90
Title
Infarct Volume
Time Frame
Change from baseline to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Lipka, MD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Neurological Institute, Dept. of Neurology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
University of California Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024-1777
Country
United States
Facility Name
Brain Matters, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Melbourne Internal Medicine Associates (MIMA)
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901-3182
Country
United States
Facility Name
Holmes Regional Medical Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805-5410
Country
United States
Facility Name
Indiana Neuroscience Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Jewish Hospital Healthcare Services, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (BIDMC)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Nevada Neurosciences Institute at Sunrise
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
University of Tennessee, College of Medicine
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
University of Texas, Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8897
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
John Hunter Hospital
City
New Lambton Heights
ZIP/Postal Code
NSW 2310
Country
Australia
Facility Name
Box Hill Hospital
City
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
ZIP/Postal Code
SA 5011
Country
Australia
Facility Name
Medizinische Universitat Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Leopold-Franzens-Universitat Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
O O Landesnervenklinik Wagner-Jauregg
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Walter Mackenzie Health Sciences Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z3J5
Country
Canada
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FIN-00029 HUS
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
FIN-70211
Country
Finland
Facility Name
Neurologische Universitatsklinik
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinik und Poliklinik der Universitat Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Neurologische Klinik Universitat Ulm
City
Ulm
ZIP/Postal Code
49 (0) 731 500 50986
Country
Germany
Facility Name
University Hospital Amsterdam Department Neurology
City
Amsterdam
ZIP/Postal Code
1105 DD
Country
Netherlands
Facility Name
University Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22738918
Citation
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.
Results Reference
derived
PubMed Identifier
22474060
Citation
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.
Results Reference
derived
PubMed Identifier
19097942
Citation
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.
Results Reference
derived

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

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