Randomized controlled phase II trial to test the safety and preliminary efficacy of a dual thrombolytic treatment consisting of a small intravenous (IV) bolus of alteplase followed by IV infusion of mutant pro-urokinase against usual treatment with IV alteplase in patients presenting with ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Intravenous administration
Intravenous administration
DUMAS trial office
Rotterdam, Netherlands
Any intracranial hemorrhage according to the Heidelberg Bleeding Classification on MRI
Time frame: 24-48 hours post-treatment
Score on the National Institutes of Health Stroke Scale (NIHSS)
The NIHSS measures neurological deficit, ranging from 0 to 42, with higher scores indicating more severe neurological deficit.
Time frame: at 24 hours and 5-7 days post-treatment
Score on the modified Rankin Scale (mRS)
The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death) measuring the degree of disability or dependence in everyday life.
Time frame: at 30 days
Infarct volume on MRI
Time frame: at 24-48 hours
Change (pre-treatment vs. post-treatment) in abnormal perfusion volume based on TTP/MTT maps measured with CT perfusion at baseline and MRI
Time frame: at 24-48 hours post treatment.
Secondary blood biomarkers of thrombolysis: d-dimer levels and fibrinogen levels.
Time frame: 1 hour post-treatment, after 3 hours, and after 24 hours post-treatment,
Symptomatic intracranial hemorrhage (sICH) according to the Heidelberg Bleeding Classification
sICH is defined as any intracranial hemorrhage followed by a neurological deterioration that can be attributed to that hemorrhage, defined as an increase of \>= 4 points on the NIHSS or \>= 2 points on a specific NIHSS item.
Time frame: within 30 days
Death from any cause
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Time frame: Within 30 days
Major extracranial hemorrhage according to the ISTH criteria
Time frame: within 24 hours of study drug administration