No registrations found.
ID
Source
Brief title
Health condition
Stroke, Ischemic stroke, Thrombolytic therapy, Treatment
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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)
Background 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-urokianse against usual treatment with IV alteplase in patients presenting with ischemic stroke.
Study objective
To 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
Study design
30 day follow-up
Intervention
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).
DUMAS trial office
Rotterdam 3000 CA
The Netherlands
0639583967
dumas@erasmusmc.nl
DUMAS trial office
Rotterdam 3000 CA
The Netherlands
0639583967
dumas@erasmusmc.nl
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7409 |
| NTR-old | NTR7634 |
| Other | METC Erasmus MC : 2018-00448-42 EudraCT |