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Completed

NCT Number: NCT00111852

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

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

John Hunter Hospital, New Lambton Heights, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Desmoteplase

Drug

Desmoteplase 90 mcg/kg, intravenous administration.

Placebo

Drug

Dose-Match Placebo, intravenous administration.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
First posted
May 27, 2005
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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