Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS) "DEDAS"

Completed

Phase 1/2 Results N/A

Trial Description

The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.

Detailed Description

Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability in adults. The outcome can be improved by early treatment with thrombolysis. Alteplase (r-tPA) is the only approved thrombolytic drug in the indication of acute ischemic stroke. However, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. As the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile.
Desmoteplase (DSPA) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

Conditions

Interventions

  • Desmoteplase Drug
    Intervention Desc: Desmoteplase 125 µg/kg BW i.v. bolus
    ARM 1: Kind: Experimental
    Label: 1
    Description: Desmoteplase 90µg/kg BW
    ARM 2: Kind: Experimental
    Label: 2
    Description: Desmoteplase 125 µg/kg BW
  • Placebo Drug
    Intervention Desc: Placebo i.v. bolus
    ARM 1: Kind: Experimental
    Label: 3
    Description: Placebo

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS Day 90 No
Primary Reperfusion after 4-8 h 8 h No
Primary Infarct lesion volume after 30 days Day 30 No
Primary Safety & pharmacokinetic outcomes Day 90 No

Sponsors