Conditions: Stroke
Keywords: Acute ischemic stroke Angiography Desmoteplase Thrombolytic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 270
Healthy volunteers: no

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 to 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 to 9 hours after onset of stroke symptoms.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Desmoteplase intervention 2: Placebo
Intervention descriptions: intervention 1: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day intervention 2: IV, single bolus over 1 to 2 minutes on 1st day

Protocol document: