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

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 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Change from Baseline to day 90 ] [ Designated as safety issue: No ]
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).
Modified Rankin Scale (MRS) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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).
Barthel Index (BI) score of 75-100. [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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:

Percentage of patients with improvement in NIHSS score [ Time Frame: From Baseline to Day 90 ] [ Designated as safety issue: No ]
Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1.
Percentage of patients with MRS score of 0-2 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Percentage of patients with BI score of 75-100 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Infarct Volume [ Time Frame: Change from baseline to Day 30 ] [ Designated as safety issue: No ]

Enrollment:	193
Study Start Date:	April 2005
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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, 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.

Contacts and Locations

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

Show 44 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators

Study Director:

Leslie Lipka, MD

Forest Laboratories

More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fiebach JB, Al-Rawi Y, Wintermark M, Furlan AJ, Rowley HA, Lindstén 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. Epub 2012 Apr 3.

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00111852 History of Changes
Other Study ID Numbers:	DSP-MD-01
Study First Received:	May 26, 2005
Last Updated:	March 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Desmoteplase
Acute Ischemic Stroke
Stroke, Acute

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction

Brain Ischemia
Salivary plasminogen activator alpha 1, Desmodus rotundus
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013