Status:
COMPLETED
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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 3-9 hours from onset of stroke symptoms.
Detailed Description
Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the major...
Eligibility Criteria
Inclusion
- Diagnosis of acute ischemic stroke
- Informed consent
- Age between 18 and 85 years
- Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
- NIHSS Score of 4-24
- Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT00790920
Start Date
December 1 2008
Last Update
September 18 2015
Active Locations (102)
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1
AU006
Clayton, Australia, 3168
2
AU004
Gosford, Australia, 2250
3
AU001
Melbourne, Australia
4
AU002
Melbourne, Australia