Clinical trial NCT02603406: Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits
Official title: Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Angiogenesis
Ischemic Stroke
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2015-11-11
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)


Eligibility criteria: 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)

Primary outcomes:
measure: Successful new vascularization of internal-to-external cerebral collateral flow
timeFrame: 6 months
Secondary outcomes:
measure: Early Neurological Deterioration (END) during admission
timeFrame: 14 days
measure: Adverse events during the study period
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
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