NCT00790920

Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 492 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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 3-9 hours after onset of stroke symptoms.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	Desmoteplase	90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
DRUG	Placebo	IV, single bolus over 1 - 2 minutes on 1st day

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-07-01
• First posted: 2008-11-14
• Last updated: 2015-09-18

Locations

102 sites across 17 countries: Australia, Austria, Estonia, France, Germany, Hong Kong, India, Netherlands, Philippines, Poland, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Vietnam