Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Modified Rankin Scale Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day
|Placebo Comparator: Placebo||
IV, single bolus over 1 to 2 minutes on 1st day
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 majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.
The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3 to 9 hours after onset of stroke symptoms.
|Contact: Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|
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|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|