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Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
Not Recruiting
Trial ID: NCT00856661
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
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
Anna Finley Caulfield, MD
Clinical Professor, Neurology & Neurological Sciences
Marion S. Buckwalter, MD, PhD
Professor of Neurology (Adult Neurology) and of Neurosurgery
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
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
Intervention(s):
drug: Placebo
drug: Desmoteplase
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maarten Lansberg
6507234448