Dual thrombolytic therapy with mutant pro-urokinase and low dose alteplase for ischemic stroke
Recruiting
- Conditions
- Stroke, Ischemic stroke, Thrombolytic therapy, Treatment
- Registration Number
- NL-OMON29554
- Lead Sponsor
- Erasmus Medical Center, ROtterdam
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
A clinical diagnosis of ischemic stroke;
-A score of at least 1 on the NIH Stroke Scale;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Score on the NIHSS assessed at 24 hours and 5-7 days post-treatment.<br /><br>- Improvement of at least 4 points on NIHSS at 24 hours compared to baseline, or (near) complete recovery (NIHSS 0 or 1)<br /><br>- Score on the mRS assessed at 90 days<br /><br>- Infarct volume with MRI at 24 hours<br /><br>- Secondary blood biomarkers of thrombolysis (including fibrinogen and d-dimer)