Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS)
Primary Purpose
Angiogenesis, Ischemic Stroke
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Angiogenesis
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
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
mechanical barrier disruption procedure Drug: no-specific intervention
Outcomes
Primary Outcome Measures
Successful new vascularization of internal-to-external cerebral collateral flow
transdural neovascularization: absent vs. present) from 6- vessel angiography
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02603406
First Posted
November 10, 2015
Last Updated
August 17, 2020
Sponsor
Ajou University School of Medicine
Collaborators
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02603406
Brief Title
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits
Acronym
NIMBUS
Official Title
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2016 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angiogenesis, Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B
Arm Type
No Intervention
Arm Description
mechanical barrier disruption procedure Drug: no-specific intervention
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
eporon
Primary Outcome Measure Information:
Title
Successful new vascularization of internal-to-external cerebral collateral flow
Description
transdural neovascularization: absent vs. present) from 6- vessel angiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Early Neurological Deterioration (END) during admission
Description
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
Time Frame
14 days
Title
Adverse events during the study period
Description
Overall adverse events (early neurological deterioration; adverse events within 7 days after operation; and adverse events during the study period
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
12. IPD Sharing Statement
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Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits
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