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Stroke, AcutePhase 3NCT00111852

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

A Phase 3 study testing Desmoteplase in people with Stroke, Acute, run by Forest Laboratories at 44 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke, Acute
What is being tested?
Desmoteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
193 participants
Where
44 sitesin 8 countries
Study dates
Apr 2005to Mar 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

44 sites in 8 countries.

44 sites in 8 countries

United States28 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Alabama Neurological Institute, Dept. of Neurology

    Birmingham, Alabama, 35209

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

  • Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • University of Tennessee, College of Medicine

    Chattanooga, Tennessee, 37404

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • University of Texas, Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8897

  • Brain Matters, Inc.

    Delray Beach, Florida, 33445

  • JFK Medical Center

    Edison, New Jersey, 08818

  • Parkview Hospital

    Fort Wayne, Indiana, 46805-5410

  • The Methodist Hospital

    Houston, Texas, 77030

  • Indiana Neuroscience Institute

    Indianapolis, Indiana, 46260

  • Nevada Neurosciences Institute at Sunrise

    Las Vegas, Nevada, 89109

  • University of California Los Angeles Medical Center

    Los Angeles, California, 90024-1777

  • Jewish Hospital Healthcare Services, Inc.

    Louisville, Kentucky, 40202

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Melbourne Internal Medicine Associates (MIMA)

    Melbourne, Florida, 32901-3182

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • Saint Thomas Hospital

    Nashville, Tennessee, 37205

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Winchester Medical Center

    Winchester, Virginia, 22601

Other trials in United States

Australia3 sites

  • John Hunter Hospital

    New Lambton Heights, NSW 2310

  • Box Hill Hospital

    Victoria, 3128

  • Queen Elizabeth Hospital

    Woodville, SA 5011

Other trials in Australia

Austria3 sites

  • Medizinische Universitat Graz

    Graz, 8036

  • Leopold-Franzens-Universitat Innsbruck

    Innsbruck, 6020

  • O O Landesnervenklinik Wagner-Jauregg

    Linz, 4020

Other trials in Austria

Germany3 sites

  • Neurologische Universitatsklinik

    Bonn, 53105

  • Klinik und Poliklinik der Universitat Leipzig

    Leipzig, 04103

  • Neurologische Klinik Universitat Ulm

    Ulm, 49 (0) 731 500 50986

Other trials in Germany

Canada2 sites

  • Walter Mackenzie Health Sciences Centre

    Edmonton, Alberta, T6G2B7

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z3J5

Other trials in Canada

Finland2 sites

  • Helsinki University Central Hospital

    Helsinki, FIN-00029 HUS

  • Kuopio University Hospital

    Kuopio, FIN-70211

Other trials in Finland

Spain2 sites

  • University Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitari Doctor Josep Trueta

    Girona, 17007

Other trials in Spain

Netherlands1 site

  • University Hospital Amsterdam Department Neurology

    Amsterdam, 1105 DD

Other trials in Netherlands

About this 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

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.

Conditions
Stroke, Acute
Being tested
Desmoteplase, Placebo
Keywords
Desmoteplase, Acute Ischemic Stroke, Stroke, Acute
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DesmoteplaseDrug

    Desmoteplase 90 mcg/kg, intravenous administration.

  • DesmoteplaseDrug

    Desmoteplase 125 mcg/kg, intravenous administration.

  • PlaceboDrug

    Dose-Match Placebo, intravenous administration.

Study groups in NCT00111852
Study groupRoleWhat they receive
Desmoteplase, low doseExperimentalDesmoteplase 90 mcg/kg, intravenous administration.
Receives: Drug: Desmoteplase
Desmoteplase, high doseExperimentalDesmoteplase 125 mcg/kg, intravenous administration.
Receives: Drug: Desmoteplase
PlaceboPlacebo comparatorDose-Match Placebo, intravenous administration.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from Baseline to day 90

  2. 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).

    Measured: Day 90

  3. 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)

    Measured: Day 90

Secondary outcomes (4)

  1. 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.

    Measured: From Baseline to Day 90

  2. Percentage of patients with MRS score of 0-2

    Measured: Day 90

  3. Percentage of patients with BI score of 75-100

    Measured: Day 90

  4. Infarct Volume

    Measured: Change from baseline to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111852
Sponsor's protocol ID
DSP-MD-01
Status last verified
Mar 2012
First submitted
26 May 2005
Last updated
20 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22738918

  • 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.

    PubMed 22474060

  • 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.

    PubMed 19097942

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desmoteplase in people with Stroke, Acute, run by Forest Laboratories at 44 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Australia, Austria, Germany, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health Stroke Scale (NIHSS) (time frame: Change from Baseline to day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111852, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.

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