Dual thrombolytic therapy with mutant pro-urokinase (m-pro-urokinase, HisproUK) and low dose alteplase for ischemic stroke
- Conditions
- brain infarctionIschemic Stroke1000796310014523
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
- A clinical diagnosis of acute ischemic stroke;
- A score of at least 1 on the NIH Stroke Scale;
- CT or MRI ruling out intracranial hemorrhage;
-Treatment is possible
o within 4.5 hours from symptom onset or last seen well, or
o between 4.5 to 12 hours from symptom onset or last seen well, if the infarct
core is less than 25 mL and a penumbra is at least the same size as the infarct
core (i.e. total ischemic volume/infarct core mismatch >= 2.0),5 or 3)
* In case of lacunar syndrome,25 if there is a diffusion-weighted imaging and
FLAIR mismatch4;*
- Meet the criteria for standard treatment for IV alteplase according to
national guidelines;
- Contra-indication for an MRI scan (e.g., an MRI incompatible pacemaker and
metal foreign bodies)
- Age of 18 years or older;
- Written informed consent (deferred).
- Candidate for endovascular thrombectomy (i.e., no proximal intracranial large
artery occlusion on CTA or MRA)
- Contra-indication for treatment with IValteplase
- Pre-stroke disability which interferes with the assessment of functional
outcome at 30 days, i.e. mRS > 2.
- Known pregnancy or if pregnancy cannot be excluded, i.e. adequate use of any
contraceptive method (e.g. intrauterine devices) or sterilization of the
subject herself
- Participation in medical or surgical intervention trials other than DUMAS (or
MR ASAP/ARTEMIS)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is any post-intervention intracranial haemorrhage on MRI<br /><br>according to the Heidelberg Bleeding Classification within 24-48 hours of study<br /><br>drug administration. </p><br>
- Secondary Outcome Measures
Name Time Method