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

Tracking Information
First Received Date ^ICMJE	May 26, 2005
Last Updated Date	December 4, 2007
Start Date ^ICMJE	April 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00111852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Stroke, Acute
Intervention ^ICMJE	Drug: Desmoteplase
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	186
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Canada, Finland, Germany, Netherlands, Spain

Administrative Information
NCT ID ^ICMJE	NCT00111852
Responsible Party
Study ID Numbers ^ICMJE	DSP-MD-01
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Forest Laboratories
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP