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Trial record 4 of 5 for:    21127304 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02603406
Recruitment Status : Unknown
Verified September 2015 by Ji Man Hong, Ajou University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Ji Man Hong, Ajou University School of Medicine

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

Condition or disease Intervention/treatment Phase
Angiogenesis Ischemic Stroke Drug: erythropoietin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)
Study Start Date : December 2015
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
mechanical barrier disruption procedure + hrEPO manufactured by Dong-A pharmaceutics Multiple burrholes with local anesthesia after medication Drug: Erythropoietin 33,000u daily for 3 day via intravenous
Drug: erythropoietin
Other Name: eporon

No Intervention: Group B
conventional medical therapy Drug: no-specific intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute period (ischemic stroke confirmation on DWI or TIA within 7 days after symptom onset)
  • Below 20 point of initial NIHSS score within 7 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)
  • 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
  • Previous treatment with erythropoietin
  • At screening: Hemoglobin >15 mg/dl, prolonged PT or PTT, serum Cr >2.0 mg/dl,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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603406


Contacts
Contact: Ji Man Hong, MD,PhD 82 31 219 5174 dacda@hanmail.net

Sponsors and Collaborators
Ajou University School of Medicine
Dong-A ST Co., Ltd.

Publications:

Responsible Party: Ji Man Hong, Associate professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02603406     History of Changes
Other Study ID Numbers: AJIRB-MED-CT2-15-187-HJM
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Epoetin Alfa
Hematinics