Angiogenesis, Ischemic Stroke
Conditions
Brief summary
Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)
Interventions
DRUGerythropoietin
Sponsors
Dong-A Pharmaceutical Co., Ltd.
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age 20\ 85 * Acute period (ischemic stroke confirmation on DWI or TIA within 14 days after symptom onset) * Below 20 point of initial NIHSS score within 14 days after stroke onset and enrolment. * Confirmation of atherosclerotic or steno-occlusive stroke mechanism (proximal cerebral arteries) on CTA or MRA . * At least hemodynamically, perfusion status of a candidate is stage II or III (decrease of regional Cerebral blood flow on CBF map), moyamoya disease * If female then not of childbearing potential * Informed consent
Exclusion criteria
* Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm * Treated with a thrombolytic \<24 hours (if \>24 hours and excluded ICH then eligible) * Score \>=1 on the NIHSS item 1a * Pre-stroke mRS score \<2 * Uncontrolled hypertension(irregularity systollic BP \> 150mmHg * Previous treatment with erythropoietin * At screening: Hemoglobin \>14 g/dl, prolonged PT or PTT, serum Cr \>2.0 ,mg/dl, BUN \>40, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of \> 1800/mm3 required for participation), or \> 2 times of normal on liver function tests (SGOT, SGPT, total bilirubin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful new vascularization of internal-to-external cerebral collateral flow | 6 months | transdural neovascularization: absent vs. present) from 6- vessel angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Neurological Deterioration (END) during admission | 14 days | NIHSS scores are daily assessed during admission and neurological deterioration is designated as at least 2-point decrease of NIHSS during 14 days after admission |
| Adverse events during the study period | up to 6 months | Overall adverse events (early neurological deterioration; adverse events within 7 days after operation; and adverse events during the study period |
Outcome results
None listed