Stroke
Conditions
Keywords
Acute ischemic stroke
Brief summary
The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.
Detailed description
Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability. 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.
Interventions
Desmoteplase 62.5 µg/kg BW
Placebo
Sponsors
Study design
Eligibility
Inclusion criteria
* scoring 4 to 20 on the National Institute of Health Stroke Scale (NIHSS) * showing a perfusion-diffusion mismatch on MRI of 20 % * enrolment within a 3 h to 9 h time window after symptom onset. * 18-85 years of age
Exclusion criteria
* Participation in any interventional trial in the previous 30 days. * Women in the childbearing age. * Any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm, arteriovenous malformation or aneurysm. * Conditions that, according to the judgment of the investigator, might impose an additional risk to any individual stroke patient when receiving study medication (this applied to patients on platelet-function inhibitors as well). * MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS | Day 90 |
| Change in lesion volume | Day 30 |
Secondary
| Measure | Time frame |
|---|---|
| Reperfusion after 4-8 h | 8 h |
| Safety and pharmacoeconomic outcomes | Day 90 |
Countries
Germany