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Dual thrombolytic therapy with mutant pro-urokinase (HisproUK) and low dose alteplase for ischemic stroke


- candidate number30023
- NTR NumberNTR7634
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-nov-2018
- Secondary IDs2018-00448-42 EudraCT 
- Public TitleDual thrombolytic therapy with mutant pro-urokinase (HisproUK) and low dose alteplase for ischemic stroke
- Scientific TitleDual thrombolytic therapy with mutant pro-urokinase (HisproUK) and low dose alteplase for ischemic stroke
- ACRONYMDUMAS
- hypothesisTo test the safety and preliminary efficacy of a dual acute thrombolytic treatment consisting of a small intravenous (IV) bolus of alteplase followed by IV infusion of HisproUK against usual treatment with IV alteplase in patients presenting with ischemic stroke
- Healt Condition(s) or Problem(s) studiedStroke, Ischemic stroke, Thrombolytic therapy
- 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- 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2019
- planned closingdate1-feb-2020
- Target number of participants200
- InterventionsBolus 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/hr during 60 minutes) or a higher dose (50mg/hr during 60 minutes).
- Primary outcomeThe 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- 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)
- TimepointsInclusion starts after METC approval and ends after inclusion after inclusion of 200 patients (approximately 18 months later. 3 month follow-up.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESDr. D.W.J. Dippel
- CONTACT for SCIENTIFIC QUERIESDr. D.W.J. Dippel
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Thrombolytic Science International (TSI)
- PublicationsNone
- Brief summaryRandomized 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-urokianse against usual treatment with IV alteplase in patients presenting with ischemic stroke.
- Main changes (audit trail)
- RECORD26-nov-2018 - 10-dec-2018


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