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

Ischemic Stroke Clinical Trial

— NIMBUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603406
• Other study ID #: AJIRB-MED-CT2-15-187-HJM
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 31, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Angiogenesis
• Ischemic Stroke
• Neovascularization, Pathologic

Intervention

Drug:
• erythropoietin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Dong-A Pharmaceutical Co., Ltd.

References & Publications (26)

Appireddy RM, Demchuk AM, Goyal M, Menon BK, Eesa M, Choi P, Hill MD. Endovascular therapy for ischemic stroke. J Clin Neurol. 2015 Jan;11(1):1-8. doi: 10.3988/jcn.2015.11.1.1. Epub 2015 Jan 2. Review. — View Citation

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Demchuk AM, Goyal M, Menon BK, Eesa M, Ryckborst KJ, Kamal N, Patil S, Mishra S, Almekhlafi M, Randhawa PA, Roy D, Willinsky R, Montanera W, Silver FL, Shuaib A, Rempel J, Jovin T, Frei D, Sapkota B, Thornton JM, Poppe A, Tampieri D, Lum C, Weill A, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times (ESCAPE) trial: methodology. Int J Stroke. 2015 Apr;10(3):429-38. doi: 10.1111/ijs.12424. Epub 2014 Dec 25. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful new vascularization of internal-to-external cerebral collateral flow	transdural neovascularization: absent vs. present) from 6- vessel angiography	6 months
Secondary	Early Neurological Deterioration (END) during admission	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	14 days
Secondary	Adverse events during the study period	Overall adverse events (early neurological deterioration; adverse events within 7 days after operation; and adverse events during the study period	up to 6 months