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

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00111852

Purpose

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	Intervention	Phase
Stroke, Acute	Drug: Desmoteplase	Phase III

Drug Information available for: Desmoteplase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Clinical improvement at day 90 defined for each patient as achievement of all three of the following criteria
Improvement of greater than or equal to 8 points from baseline on the National Institutes of Health Stroke Scale (NIHSS) (or NIHSS score less than or equal to 1)
Modified Rankin Scale (MRS) score of 0-2
Barthel Index (BI) score of 75-100.

Secondary Outcome Measures:

Include the following
percentage (%) of patients with improvement of greater than or equal to 8 points from baseline on the NIHSS (or NIHSS score less than or equal to 1) at Day 90
percentage (%) of patients with MRS score of 0-2 at day 90
percentage (%) of patients with BI score of 75-100 at Day 90
change from baseline in infarct volume at Day 30.

Estimated Enrollment:	186
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, arterio-venous 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111852

Show 44 Study Locations

Sponsors and Collaborators

Forest Laboratories

More Information

Study ID Numbers:	DSP-MD-01
Study First Received:	May 26, 2005
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00111852
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Desmoteplase
Acute Ischemic Stroke
Stroke, Acute

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Brain Infarction

Ischemia
Brain Diseases
Infarction
Plasminogen
Salivary plasminogen activator alpha 1, Desmodus rotundus
Cerebrovascular Disorders

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Nervous System Diseases

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009