Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
Trial ID or NCT#
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.
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
- - 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
- - 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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