Acute ischemic stroke with recent ingestion of direct oral anticoagulants.
Conditions
Brief summary
modified Rankin Scale (mRS, functional outcome) at 90 days ± 2 weeks (shift analysis)
Detailed description
Dichotomized good functional outcome (mRS 0-2 or return to baseline at day 90 (±2 weeks)), change in stroke severity (National Institutes of Health Stroke Scale and ischemic stroke volume) between baseline and 24 ± 12 hours, health-related Quality of Life (EuroQol 5D-3L) at 90 days ± 2 weeks, symptomatic intracranial hemorrhage within the first 36 hours (European Co-operative Acute Stroke Study-II definition), major extracranial bleeding up to 24 ± 12 hours, all-cause mortality up to 7 days after admission or until discharge
Interventions
DRUGMetalyse 10 000 units (50 mg) powder and solvent for solution for injection
DRUGActilyse® Pulver und Lösungsmittel zur Herstellung einer Injektions- bzw. Infusionslösung
Sponsors
Insel Gruppe AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Rankin Scale (mRS, functional outcome) at 90 days ± 2 weeks (shift analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dichotomized good functional outcome (mRS 0-2 or return to baseline at day 90 (±2 weeks)), change in stroke severity (National Institutes of Health Stroke Scale and ischemic stroke volume) between baseline and 24 ± 12 hours, health-related Quality of Life (EuroQol 5D-3L) at 90 days ± 2 weeks, symptomatic intracranial hemorrhage within the first 36 hours (European Co-operative Acute Stroke Study-II definition), major extracranial bleeding up to 24 ± 12 hours, all-cause mortality up to 7 days after admission or until discharge | — |
Countries
Belgium, Finland, France, Germany, Netherlands, Portugal, Spain
Outcome results
None listed