Dual Thrombolytic Therapy With Mutant Pro-urokinase and Low Dose Alteplase for Ischemic Stroke

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Erasmus Medical Center
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Updated on 16 February 2024
See if I qualify
stroke
intracranial hemorrhage
thrombolytic drugs
thrombolytic agent
tissue plasminogen activator
alteplase
iv infusion
urokinase
thrombolytic therapy
plasminogen activator
plasminogen

Summary

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.

Details
Condition Ischemic Stroke
Age 18years - 100years
Treatment Alteplase, mutant pro-urokinase
Clinical Study IdentifierNCT04256473
SponsorErasmus Medical Center
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 guidelines27
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 treatment with IV alteplase according to national guidelines27
Arterial blood pressure exceeding 185/110 mmHg and not responding to treatment
Blood glucose less than 2.7 or over 22.2 mmol/L
Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
Head trauma in the previous 4 weeks
Major surgery or serious trauma in the previous 2 weeks
Gastrointestinal or urinary tract hemorrhage in the previous 2 weeks
Previous intracerebral hemorrhage
Use of anticoagulant with INR exceeding 1.7 or APTT exceeding 50 seconds
Known thrombocyte count less than 90 x 109 /L
Treatment with direct thrombin or factor X inhibitors, unless specific antidotum has been given, i.e. idarucizumab in case of dabigatran use
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
an MRI incompatible pacemaker, ICD, pacing wires and loop records
metallic foreign bodies (e.g. intra-ocular)
prosthetic heart valves
blood vessel clips, coils or stents
an implanted electronic and/or magnetic implant or pump (e.g. neurostimulator)
cochlear implants
mechanical implants (implanted less than 6 weeks ago)
a copper intrauterine device
Current Participation in any medical or surgical therapeutic trial other than DUMAS
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