Overview

Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits

Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
0
Participant gender:
All
Summary
Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ajou University School of Medicine
Collaborators:
Dong-A Pharmaceutical Co., Ltd.
Dong-A ST Co., Ltd.
Treatments:
Epoetin Alfa
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)