DIAS-4 Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
DIAS-4 is a phase III study, sponsored by Lundbeck to evaluate the efficacy and safety of desmoteplase in study participants with acute ischemic stroke. It is a follow-on to the DIAS-3 study which completed in March-2014. BIOS (Brain Injury Outcomes Clinical Trial Coordinating Center) is acting as a local coordinating team for this study at Johns Hopkins.
Desmoteplase is an investigational recombinant tissue plasminogen activator (rt-PA). Early studies suggest is may have a lower bleeding risk than alteplase when given via intravenous administration in ischemic stroke. It has a broader time window (up to 9 hours) and can be given as a single bolus injection making it easier to use.
The primary outcome measure is the score on the 90-day Modified Rankin Scale. The NIHSS at Day-90 is a secondary outcome measure.
This therapeutic agent was initially discovered in the saliva of a vampire bat.