Trial | NCT04256473  Report issue

Title

Dual Thrombolytic Therapy With Mutant Pro-urokinase and Low Dose Alteplase for Ischemic Stroke
Dual Thrombolytic Therapy With Mutant Pro-urokinase (M-pro-urokinase, HisproUK) and Low Dose Alteplase for Ischemic Stroke

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
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 Started
Aug 10
2019
Primary Completion
Mar 26
2022
Study Completion
May 26
2022
Last Update
Sep 07
2023

Drug mutant pro-urokinase

Intravenous administration

  • Other names: HisproUK

Drug Alteplase

Intravenous administration

  • Other names: Actilyse

Intervention Experimental

Bolus 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).

Control Active Comparator

Usual care with alteplase 0.9 mg/kg in 60 minutes

Criteria 

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.
No Results Posted