drugset / Trial / NCT02603406
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits
Phase 2
Completed
44 enrolled
Ajou University School of Medicine
Dong-A Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)
Timeline
- Start
- 2016-07-15
- Primary completion
- 2019-07-16
- Completion
- 2019-12-31
Publications
- Background Hong KS, Bang OY, Kang DW, Yu KH, Bae HJ, Lee JS, Heo JH, Kwon SU, Oh CW, Lee BC, Kim JS, Yoon BW. Stroke statistics in Korea: part I. Epidemiology and risk factors: a report from the korean stroke society and clinical research center for stroke. J Stroke. 2013 Jan;15(1):2-20. doi: 10.5853/jos.2013.15.1.2. Epub 2013 Jan 31.
- Background Rosamond WD, Folsom AR, Chambless LE, Wang CH, McGovern PG, Howard G, Copper LS, Shahar E. Stroke incidence and survival among middle-aged adults: 9-year follow-up of the Atherosclerosis Risk in Communities (ARIC) cohort. Stroke. 1999 Apr;30(4):736-43. doi: 10.1161/01.str.30.4.736.
- Background 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.
- Background 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.
- Background Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.
- Background Hill MD, Goyal M, Demchuk AM. Endovascular stroke therapy--a new era. Int J Stroke. 2015 Apr;10(3):278-9. doi: 10.1111/ijs.12456. No abstract available.
- Background Clinical alert: benefit of carotid endarterectomy for patients with high-grade stenosis of the internal carotid artery. National Institute of Neurological Disorders and Stroke Stroke and Trauma Division. North American Symptomatic Carotid Endarterectomy Trial (NASCET) investigators. Stroke. 1991 Jun;22(6):816-7. doi: 10.1161/01.str.22.6.816. No abstract available.
- Background Yamauchi H, Kudoh T, Kishibe Y, Iwasaki J, Kagawa S. Selective neuronal damage and chronic hemodynamic cerebral ischemia. Ann Neurol. 2007 May;61(5):454-65. doi: 10.1002/ana.21104.
- Background Goldstein LB, Bushnell CD, Adams RJ, Appel LJ, Braun LT, Chaturvedi S, Creager MA, Culebras A, Eckel RH, Hart RG, Hinchey JA, Howard VJ, Jauch EC, Levine SR, Meschia JF, Moore WS, Nixon JV, Pearson TA; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Epidemiology and Prevention; Council for High Blood Pressure Research,; Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Feb;42(2):517-84. doi: 10.1161/STR.0b013e3181fcb238. Epub 2010 Dec 2.
- Background Hobson RW 2nd, Weiss DG, Fields WS, Goldstone J, Moore WS, Towne JB, Wright CB. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group. N Engl J Med. 1993 Jan 28;328(4):221-7. doi: 10.1056/NEJM199301283280401.
- Background Ogasawara K, Ogawa A, Terasaki K, Shimizu H, Tominaga T, Yoshimoto T. Use of cerebrovascular reactivity in patients with symptomatic major cerebral artery occlusion to predict 5-year outcome: comparison of xenon-133 and iodine-123-IMP single-photon emission computed tomography. J Cereb Blood Flow Metab. 2002 Sep;22(9):1142-8. doi: 10.1097/00004647-200209000-00012.
- Background Grubb RL Jr, Derdeyn CP, Fritsch SM, Carpenter DA, Yundt KD, Videen TO, Spitznagel EL, Powers WJ. Importance of hemodynamic factors in the prognosis of symptomatic carotid occlusion. JAMA. 1998 Sep 23-30;280(12):1055-60. doi: 10.1001/jama.280.12.1055.
- Background Powers WJ, Clarke WR, Grubb RL Jr, Videen TO, Adams HP Jr, Derdeyn CP; COSS Investigators. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA. 2011 Nov 9;306(18):1983-92. doi: 10.1001/jama.2011.1610.
- Background Kuroda S, Ishikawa T, Houkin K, Nanba R, Hokari M, Iwasaki Y. Incidence and clinical features of disease progression in adult moyamoya disease. Stroke. 2005 Oct;36(10):2148-53. doi: 10.1161/01.STR.0000182256.32489.99. Epub 2005 Sep 22.
- Background Kelly ME, Bell-Stephens TE, Marks MP, Do HM, Steinberg GK. Progression of unilateral moyamoya disease: A clinical series. Cerebrovasc Dis. 2006;22(2-3):109-15. doi: 10.1159/000093238. Epub 2006 May 9.
- Background Chiu D, Shedden P, Bratina P, Grotta JC. Clinical features of moyamoya disease in the United States. Stroke. 1998 Jul;29(7):1347-51. doi: 10.1161/01.str.29.7.1347.
- Background Ikezaki K, Matsushima T, Kuwabara Y, Suzuki SO, Nomura T, Fukui M. Cerebral circulation and oxygen metabolism in childhood moyamoya disease: a perioperative positron emission tomography study. J Neurosurg. 1994 Dec;81(6):843-50. doi: 10.3171/jns.1994.81.6.0843.
- Background Kuwabara Y, Ichiya Y, Sasaki M, Yoshida T, Masuda K, Matsushima T, Fukui M. Response to hypercapnia in moyamoya disease. Cerebrovascular response to hypercapnia in pediatric and adult patients with moyamoya disease. Stroke. 1997 Apr;28(4):701-7. doi: 10.1161/01.str.28.4.701.
- Background Sakamoto T, Kawaguchi M, Kurehara K, Kitaguchi K, Furuya H, Karasawa J. Postoperative neurological deterioration following the revascularization surgery in children with moyamoya disease. J Neurosurg Anesthesiol. 1998 Jan;10(1):37-41. doi: 10.1097/00008506-199801000-00009.
- Background Brines M, Cerami A. Emerging biological roles for erythropoietin in the nervous system. Nat Rev Neurosci. 2005 Jun;6(6):484-94. doi: 10.1038/nrn1687.
- Background Juul S. Recombinant erythropoietin as a neuroprotective treatment: in vitro and in vivo models. Clin Perinatol. 2004 Mar;31(1):129-42. doi: 10.1016/j.clp.2004.03.004.
- Background Byts N, Siren AL. Erythropoietin: a multimodal neuroprotective agent. Exp Transl Stroke Med. 2009 Oct 21;1:4. doi: 10.1186/2040-7378-1-4.
- Background Prass K, Scharff A, Ruscher K, Lowl D, Muselmann C, Victorov I, Kapinya K, Dirnagl U, Meisel A. Hypoxia-induced stroke tolerance in the mouse is mediated by erythropoietin. Stroke. 2003 Aug;34(8):1981-6. doi: 10.1161/01.STR.0000080381.76409.B2. Epub 2003 Jun 26.
- Background Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
- Background Ehrenreich H, Weissenborn K, Prange H, Schneider D, Weimar C, Wartenberg K, Schellinger PD, Bohn M, Becker H, Wegrzyn M, Jahnig P, Herrmann M, Knauth M, Bahr M, Heide W, Wagner A, Schwab S, Reichmann H, Schwendemann G, Dengler R, Kastrup A, Bartels C; EPO Stroke Trial Group. Recombinant human erythropoietin in the treatment of acute ischemic stroke. Stroke. 2009 Dec;40(12):e647-56. doi: 10.1161/STROKEAHA.109.564872. Epub 2009 Oct 15.
- Background Nemoto EM, Yonas H, Chang Y. Stages and thresholds of hemodynamic failure. Stroke. 2003 Jan;34(1):2-3. doi: 10.1161/01.str.0000041048.33908.18. No abstract available.
- Hong JM, Choi MH, Park GH, Shin HS, Lee SJ, Lee JS, Lim YC. Transdural Revascularization by Multiple Burrhole After Erythropoietin in Stroke Patients With Cerebral Hypoperfusion: A Randomized Controlled Trial. Stroke. 2022 Sep;53(9):2739-2748. doi: 10.1161/STROKEAHA.122.038650. Epub 2022 May 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 33000 iu | Intravenous |