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

Stroke, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111852
• Other study ID #: DSP-MD-01
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2005
• Last updated: March 19, 2012
• Start date: April 2005

Study information

• Verified date: March 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 flow again in individuals suffering from ischemic stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Drug:
• Desmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.
• Desmoteplase
Desmoteplase 125 mcg/kg, intravenous administration.
• Placebo
Dose-Match Placebo, intravenous administration.

Locations

Country	Name	City	State
Australia	John Hunter Hospital	New Lambton Heights
Australia	Box Hill Hospital	Victoria
Australia	Queen Elizabeth Hospital	Woodville
Austria	Medizinische Universitat Graz	Graz
Austria	Leopold-Franzens-Universitat Innsbruck	Innsbruck
Austria	O O Landesnervenklinik Wagner-Jauregg	Linz
Canada	Walter Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	Vancouver General Hospital	Vancouver	British Columbia
Finland	Helsinki University Central Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Germany	Neurologische Universitatsklinik	Bonn
Germany	Klinik und Poliklinik der Universitat Leipzig	Leipzig
Germany	Neurologische Klinik Universitat Ulm	Ulm
Netherlands	University Hospital Amsterdam Department Neurology	Amsterdam
Spain	University Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Universitari Doctor Josep Trueta	Girona
United States	Johns Hopkins University	Baltimore	Maryland
United States	Alabama Neurological Institute, Dept. of Neurology	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Erlanger Health System	Chattanooga	Tennessee
United States	University of Tennessee, College of Medicine	Chattanooga	Tennessee
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	University of Texas, Southwestern Medical Center at Dallas	Dallas	Texas
United States	Brain Matters, Inc.	Delray Beach	Florida
United States	JFK Medical Center	Edison	New Jersey
United States	Parkview Hospital	Fort Wayne	Indiana
United States	The Methodist Hospital	Houston	Texas
United States	Indiana Neuroscience Institute	Indianapolis	Indiana
United States	Nevada Neurosciences Institute at Sunrise	Las Vegas	Nevada
United States	University of California Los Angeles Medical Center	Los Angeles	California
United States	Jewish Hospital Healthcare Services, Inc.	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	Melbourne Internal Medicine Associates (MIMA)	Melbourne	Florida
United States	Saint Thomas Hospital	Nashville	Tennessee
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	Tampa General Hospital	Tampa	Florida
United States	Winchester Medical Center	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Finland,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from Baseline to day 90	No
Primary	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).	Day 90	No
Primary	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)	Day 90	No
Secondary	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.	From Baseline to Day 90	No
Secondary	Percentage of patients with MRS score of 0-2		Day 90	No
Secondary	Percentage of patients with BI score of 75-100		Day 90	No
Secondary	Infarct Volume		Change from baseline to Day 30	No