Ischemic Stroke Clinical Trial
— NIMBUSOfficial title:
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits (NIMBUS Trial)
Verified date | August 2020 |
Source | Ajou University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)
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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ajou University School of Medicine | Dong-A Pharmaceutical Co., Ltd. |
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* Note: There are 26 references in all — Click here to view all references
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 |
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