Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

Terminated

Phase 3 Results

Trial Description

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.

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

Conditions

Interventions

  • 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 Drug
    Intervention Desc: IV, single bolus over 1 to 2 minutes on 1st day
    ARM 1: Kind: Experimental
    Label: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

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

Sponsors