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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111852
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : March 20, 2012
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Drug: Desmoteplase Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2005
Actual Primary Completion Date : March 2007

Arm Intervention/treatment
Experimental: Desmoteplase, low dose
Desmoteplase 90 mcg/kg, intravenous administration.
Drug: Desmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.

Experimental: Desmoteplase, high dose
Desmoteplase 125 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.

Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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)

Secondary Outcome Measures :
  1. 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.

  2. Percentage of patients with MRS score of 0-2 [ Time Frame: Day 90 ]
  3. Percentage of patients with BI score of 75-100 [ Time Frame: Day 90 ]
  4. Infarct Volume [ Time Frame: Change from baseline to Day 30 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111852

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Sponsors and Collaborators
Forest Laboratories
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Study Director: Leslie Lipka, MD Forest Laboratories
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Forest Laboratories Identifier: NCT00111852    
Other Study ID Numbers: DSP-MD-01
First Posted: May 27, 2005    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012
Keywords provided by Forest Laboratories:
Acute Ischemic Stroke
Stroke, Acute
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Salivary plasminogen activator alpha 1, Desmodus rotundus
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action