Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

Not Recruiting

Trial ID: NCT00856661

Age - 18 Years-85 Years Condition - Stroke, Cerebrovascular Stroke, Cerebral Stroke, Ischemic Stroke Gender - ALL Accepting Healthy Volunteers - No

Purpose

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.

Official Title

A Randomised, Double-Blind, Parallel-Group Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke

Stanford Investigator(s)

Maarten Lansberg, MD, PhD
Maarten Lansberg, MD, PhD

Professor of Neurology and Neurological Sciences (Adult Neurology) and, by courtesy, of Neurosurgery

Anna Finley Caulfield, MD
Anna Finley Caulfield, MD

Clinical Professor, Neurology & Neurological Sciences

Marion S. Buckwalter, MD, PhD
Marion S. Buckwalter, MD, PhD

Professor of Neurology and Neurological Sciences (Adult Neurology) and of Neurosurgery

Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Neil Schwartz, MD, PhD
Neil Schwartz, MD, PhD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Eligibility

Inclusion Criteria:

* Diagnosis of acute ischemic stroke
* Informed consent
* Age between 18 and 85 years
* Treatment can be initiated within 3 to 9 hours after the onset of stroke symptoms
* NIHSS Score of 4 to 24
* Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries

Exclusion Criteria:

* Pre-stroke mRS \>1
* Previous exposure to desmoteplase
* Extensive early infarction on MRI or CT in any affected area
* Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
* Internal carotid artery occlusion on the side of the stroke lesion
* Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
* Treatment with oral anticoagulants and a prolonged prothrombin time
* Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
* Treatment with a thrombolytic agent within the past 72 hours

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Intervention(s):

drug: Placebo

drug: Desmoteplase

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maarten Lansberg
6507234448

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