Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Candidate for endovascular thrombectomy (i.e., a proximal intracranial large artery occlusion on CTA);
Contra-indication for treatment with IV alteplase according to national guidelines27:
Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2;
Known pregnancy or if pregnancy cannot be excluded, i.e. did not have intercourse for > 6 months and no clinical signs of pregnancy, adequate use of any contraceptive method (e.g. intrauterine devices) or sterilization of the subject herself.
Contra-indication for an MRI scan, i.e.:
Current Participation in any medical or surgical therapeutic trial other than DUMAS.
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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