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.
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.
Trial Stopped: The recruitment into DIAS4 has been stopped as the result of DIAS 3 indicates that the study is unlikely to reach its primary endpoint with the current protocol
- Desmoteplase Drug
Intervention Desc: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day ARM 1: Kind: Experimental Label: Desmoteplase
- Placebo Biological
Intervention Desc: IV, single bolus over 1 to 2 minutes on 1st day ARM 1: Kind: Experimental Label: Placebo
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients are randomized to either: Desmoteplase Score 90 ?g/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day or Placebo IV, single bolus over 1 - 2 minutes on 1st day. Imaging follow-up at 12-24 hours for safety and to assess recanalisation (optional). Follow up with a Modified Rankin Scale and National Institutes of Health Stroke Scale (NIHSS) Score is done in 90 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Scale Score|
|Secondary||National Institutes of Health Stroke Scale (NIHSS) Score|
|Primary||Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)||Day 90||No|
|Secondary||National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)||90 days||No|
|Secondary||Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)||Day 90||No|
|Secondary||Modified Ranking Scale Score (Using the Ordinal Scale)||Day 90||No|
- H. Lundbeck A/S Lead