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

Trial ID or NCT#

NCT00856661

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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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Investigator(s)

Maarten Lansberg, MD, PhD
Maarten Lansberg, MD, PhD
Stroke and vascular neurologist, General neurologist
Professor of Neurology and Neurological Sciences (Adult Neurology) and, by courtesy, of Neurosurgery
Anna Finley Caulfield, MD
Anna Finley Caulfield, MD
Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences
Marion S. Buckwalter, MD, PhD
Marion S. Buckwalter, MD, PhD
Neurocritical care specialist
Professor of Neurology and Neurological Sciences (Adult Neurology) and of Neurosurgery
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Stroke and vascular neurologist, Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Neil Schwartz, MD, PhD
Neil Schwartz, MD, PhD
Stroke and vascular neurologist, General neurologist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Contact us to find out if this trial is right for you.

Contact

Maarten Lansberg
6507234448

View on ClinicalTrials.gov