Stroke, Ischemic stroke, Thrombolytic therapy, Treatment
Conditions
Interventions
Bolus of IV alteplase (5 mg) followed by continuous infusion of HisproUK 40 mg/hr during 60 minutes. Depending on results of interim analyses, the alternate dose may be revised to a lower dose (30mg/h
Sponsors
Erasmus Medical Center, ROtterdam
Eligibility
Inclusion criteria
Inclusion criteria: - A clinical diagnosis of ischemic stroke; - A score of at least 1 on the NIH Stroke Scale; - CT ruling out intracranial hemorrhage; - Treatment possible within 4.5 hours from symptom onset or last seen well; - Meet the criteria for standard treatment for IV alteplase according to national guidelines; - Age of 18 years or older; - Written informed consent (deferred).
Exclusion criteria
Exclusion criteria: - Candidate for endovascular thrombectomy (i.e., a proximal intracranial large artery occlusion on CTA); - Contra-indication for standard treatment with IV alteplase according to national guidelines; - Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2; - Known pregnancy; - Participation in any medical or surgical intervention trial other than current.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is any post-intervention intracranial haemorrhage on MRI according to the Heidelberg Bleeding Classification within 24-48 hours of study drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Score on the NIHSS assessed at 24 hours and 5-7 days post-treatment. - Improvement of at least 4 points on NIHSS at 24 hours compared to baseline, or (near) complete recovery (NIHSS 0 or 1) - Score on the mRS assessed at 90 days - Infarct volume with MRI at 24 hours - Secondary blood biomarkers of thrombolysis (including fibrinogen and d-dimer) | — |
Contacts
Public ContactDUMAS trial office
Erasmus MC University Medical Center, Department of Neurology, suite Ee 2240a, 3015 CE Rotterdam, The Netherlands
Outcome results
None listed