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

Completed · Phase 3 · Has a placebo group

Conditions studied: Stroke, Acute

In brief

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.

Key facts

Study ID

NCT00111852

Run by

Forest Laboratories

People needed

193

Starts

2005-04-01

Last updated by the study team

2012-03-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alabama Neurological Institute, Dept. of Neurology — Birmingham, Alabama, United States
• University of California Los Angeles Medical Center — Los Angeles, California, United States
• Brain Matters, Inc. — Delray Beach, Florida, United States
• Melbourne Internal Medicine Associates (MIMA) — Melbourne, Florida, United States
• Holmes Regional Medical Center — Melbourne, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Parkview Hospital — Fort Wayne, Indiana, United States
• Indiana Neuroscience Institute — Indianapolis, Indiana, United States
• Jewish Hospital Healthcare Services, Inc. — Louisville, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States
• Nevada Neurosciences Institute at Sunrise — Las Vegas, Nevada, United States
• JFK Medical Center — Edison, New Jersey, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Erlanger Health System — Chattanooga, Tennessee, United States
• University of Tennessee, College of Medicine — Chattanooga, Tennessee, United States
• Saint Thomas Hospital — Nashville, Tennessee, United States
• University of Texas, Southwestern Medical Center at Dallas — Dallas, Texas, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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