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

March 19, 2012 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desmoteplase, low dose
Desmoteplase 90 mcg/kg, intravenous administration.
Drug: Desmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.
Drug: Desmoteplase
Desmoteplase 125 mcg/kg, intravenous administration.
Experimental: Desmoteplase, high dose
Desmoteplase 125 mcg/kg, intravenous administration.
Drug: Desmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.
Drug: Desmoteplase
Desmoteplase 125 mcg/kg, intravenous administration.
Placebo Comparator: Placebo
Dose-Match Placebo, intravenous administration.
Drug: Placebo
Dose-Match Placebo, intravenous administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 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).
Change from Baseline to day 90
Modified Rankin Scale (MRS)
Time Frame: 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).
Day 90
Barthel Index (BI) score of 75-100.
Time Frame: 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)
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with improvement in NIHSS score
Time Frame: 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.
From Baseline to Day 90
Percentage of patients with MRS score of 0-2
Time Frame: Day 90
Day 90
Percentage of patients with BI score of 75-100
Time Frame: Day 90
Day 90
Infarct Volume
Time Frame: Change from baseline to Day 30
Change from baseline to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Leslie Lipka, MD, Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 26, 2005

First Submitted That Met QC Criteria

May 26, 2005

First Posted (Estimate)

May 27, 2005

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSP-MD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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