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

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Erasmus University

Status and phase

Completed
Phase 2

Conditions

Ischemic Stroke

Treatments

Drug: Alteplase
Drug: mutant pro-urokinase

Study type

Interventional

Funder types

Other

Identifiers

NCT04256473
DUMAS-1.1

Details and patient eligibility

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

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Intervention
Experimental group
Description:
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).
Treatment:
Drug: mutant pro-urokinase
Control
Active Comparator group
Description:
Usual care with alteplase 0.9 mg/kg in 60 minutes
Treatment:
Drug: Alteplase

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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