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