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OpenTrials
Completed

NCT Number: NCT02603406

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

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

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Erythropoietin

Drug

Other names: eporon

Primary outcomes

  1. Successful new vascularization of internal-to-external cerebral collateral flow

    Time frame: 6 months

    transdural neovascularization: absent vs. present) from 6- vessel angiography

Secondary outcomes

  1. Early Neurological Deterioration (END) during admission

    Time frame: 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

  2. Adverse events during the study period

    Time frame: up to 6 months

    Overall adverse events (early neurological deterioration; adverse events within 7 days after operation; and adverse events during the study period

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

Registry information

Official study title

Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)

Acronym: NIMBUS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2015
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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