一项评价格列本脲治疗大面积脑梗死后严重脑水肿的研究

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一、临床试验项目名称
一项评价格列本脲治疗大面积脑梗死后严重脑水肿的研究

二、适应症
治疗和预防大面积脑梗死患者的重度脑水肿

三、试验介绍

关于本研究的第一部分，其主要目的为确定BIIB093与安慰剂相比是否可改善LHI受试者第90天的功能结局（采用改良Rankin量表（mRS）评估）。第1部分次要目的如下：1. 确定BIIB093与安慰剂相比是否可改善改良意向治疗(mITT)人群中第90天的总生存率。 2. 根据以0-4与5-6划分的mRS评分确定BIIB093与安慰剂相比是否可改善改良意向治疗(mITT)人群中第90天的功能结局。 3. 确定在改良意向治疗(mITT)人群中，BIIB093与安慰剂相比是否可减少第72小时（或去骨瓣减压术[DC]或仅姑息治疗[CMO]之时，以先出现者为准）的中线移位。 4. 评价BIIB093在LHI受试者中的安全性和耐受性。关于本研究的第二部分，研究目的是评价发生LHI后的长期残疾和患者结局，以及评估随访期间的安全性。

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
首都医科大学附属北京天坛医院	刘丽萍

序号	机构名称	主要研究者	国家	省（州）	城市
1	首都医科大学附属北京天坛医院	刘丽萍	中国	北京市	北京市
2	华中科技大学同济医学院附属同济医院	王芙蓉	中国	湖北省	武汉市
3	复旦大学附属华山医院	董强	中国	上海市	上海市
4	徐州医科大学附属医院	耿徳勤	中国	江苏省	徐州市
5	温州医科大学附属第一医院	何金彩	中国	浙江省	温州市
6	南通大学附属医院	季秋虹	中国	江苏省	南通市
7	上海交通大学医学院附属仁济医院	李焰生	中国	上海市	上海市
8	苏州大学附属第二医院	刘春风	中国	江苏省	苏州市
9	天津医科大学总医院	施福东	中国	天津市	天津市
10	首都医科大学宣武医院	王宁	中国	北京市	北京市
11	南京医科大学第二附属医院	吴晋	中国	江苏省	南京市
12	萍乡市人民医院	易飞	中国	江西省	萍乡市
13	中山大学附属第一医院	曾进胜	中国	广东省	广州市
14	山西医科大学第一医院	张金	中国	山西省	太原市
15	第三军医大学第三附属医院	张猛	中国	重庆市	重庆市
16	吉林大学白求恩第一医院	杨弋	中国	吉林省	长春市
17	北京大学第三医院	樊东升	中国	北京市	北京市
18	江西省人民医院	曹文锋	中国	江西省	南昌市
19	淮安市第一人民医院	田向阳	中国	江苏省	淮安市
20	广州医科大学附属第二医院	徐恩	中国	广东省	广州市
21	南昌大学第一附属医院	熊英琼	中国	江西省	南昌市
22	河北医科大学第二医院	刘亚玲	中国	河北省	石家庄市
23	西安交通大学医学院第二附属医院	张桂莲	中国	陕西省	西安市
24	安徽省立医院	王国平	中国	安徽省	合肥市
25	Valley Hospital	Altschul, Dorothea	United States	New Jersey	Ridgewood
26	Penn State University Milton S. Hershey Medical Center	Bettermann, Kerstin	United States	Pennsylvania	Hershey
27	Brigham and Women's Hospital Department of Neurology	Bevers, Matthew	United States	Massachusetts	Boston
28	Saint Luke's Hospital of Kansas City	Boutwell, Christine	United States	Missouri	Kansas City
29	UMASS Memorial Medical Center	Carandang, Raphael	United States	Massachusetts	Worcester
30	University of Maryland	Cronin, Carolyn	United States	Maryland	Baltimore
31	St. John's Hospital	Cullis, Paul	United States	Michigan	Detroit
32	Mount Sinai Hospital	Dangayach, Neha	United States	New York	New York
33	UC Health, LLC.	Foreman, Brandon	United States	Ohio	Cincinnati
34	Valley Baptist Medical Center	Hassan, Ameer	United States	Texas	Harlingen
35	Ohio State Univ College Of Medicine	Hinduja, Archana	United States	Ohio	Columbus
36	Oregon Health & Science University	Hinson, Holly	United States	Oregon	Portland
37	University of North Carolina at Chapel Hill	Huang, David	United States	North Carolina	Chapel Hill
38	Lehigh Valley Hospital - Cedar Crest	Isayev, Yevgeniy	United States	Pennsylvania	Allentown
39	Arizona Board of Regents, University of Arizona	Kidwell, Chelsea	United States	Arizona	Tucson
40	JFK Medical Center	Kirmani, Jawad	United States	New Jersey	Edison
41	SUNY Upstate Medical Center	Latorre, Julius (Gene)	United States	New York	Syracuse
42	Northwell Health	Temes, Richard	United States	New York	Manhasset
43	Beth Israel Deaconess Medical Center, Inc.	Lioutas, Vasileious-Arsenios	United States	Massachusetts	Boston
44	Rush University Medical Center	Shepherd, Starane	United States	Illinois	Chicago
45	Jersey Shore University Medical Center	Martino, Stephen	United States	New Jersey	Neptune
46	Henry Ford Hospital	Howell, Bradley	United States	Michigan	Detroit
47	Ochsner Clinic Foundation	McGrade, Harold	United States	Louisiana	New Orleans
48	University of Pennsylvania Health System	Messe, Steven	United States	Pennsylvania	Philadelphia
49	University of Pittsburgh School of Medicine	Molyneaux, Bradley	United States	Pennsylvania	Pittsburgh
50	Maine Medical Center	Muscat, Paul	United States	Maine	Portland
51	The Queens Medical Center	Nakagawa, Kazuma	United States	Hawaii	Honolulu
52	Yale New Haven Hospital	Petersen, Nils	United States	Connecticut	New Haven
53	Grady Memorial Hospital	Ratcliff, Jonathan	United States	Georgia	Atlanta
54	University of South Florida	Renati, Swetha	United States	Florida	Tampa
55	University of Kansas Medical Center Research Institute, Inc.	Abraham, Michael	United States	Kansas	Kansas City
56	Columbia University Medical Center	Roh, David	United States	New York	New York
57	Rutgers - Robert Wood Johnson Medical School	Rybinnik, Igor	United States	New Jersey	New Brunswick
58	University of Florida, Jacksonville	Silliman, Scott	United States	Florida	Jacksonville
59	Fairview Southdale Hospital	Streib, Christopher	United States	Minnesota	Minneapolis
60	Allegheny General Hospital	Cerejo, Russell	United States	Pennsylvania	Pittsburgh
61	Stanford Stroke Center	Venkatasubramanian, Chitra	United States	California	Palo Alto
62	Barrow Neurological Institute	Waters, Michael	United States	Arizona	Phoenix
63	Rhode Island Hospital Warren Alpert Medical School Brown University	Wendell, Linda	United States	Rhode Island	Providence
64	University of Florida-Gainsville	Khanna, Anna	United States	Florida	Gainesville
65	Massachusetts General Hospital	Zafar, Sahar	United States	Massachusetts	Boston
66	ProMedica Toledo Hospital	Zaidi, Syed	United States	Ohio	Toledo
67	University of Rochester Medical Center	Benesch, Curtis	United States	New York	Rochester
68	Providence Brain and Spine Institute	Zurasky, John	United States	Oregon	Portland
69	Augusta University	Bruno, Askiel	United States	Georgia	Augusta
70	Vanderbilt Medical Center	Mittal, Shilpi	United States	Tennessee	Nashville
71	Duke University Medical Center	Shah, Shreyansh	United States	North Carolina	Durham
72	University of Utah Neurology	Chung, Lee	United States	Utah	Salt Lake City
73	Lyerly Neurosurgery Baptist Health	Naval, Neeraj	United States	Florida	Jacksonville
74	University of Louisville	Liu, Wei	United States	Kentucky	Louisville
75	NYU Langone Medical Center	Czeisler, Barry	United States	New York	New York
76	University Hospitals Cleveland Medical Center	Ramos-Estebanez, Ciro	United States	Ohio	Cleveland
77	University of Washington School of Medicine	Tirschwell, David	United States	Washington	Seattle
78	Saint Louis University	Ramiro, Joanna Isabelle I.	United States	Missouri	St. Louis
79	Wake Forest Baptist Health	Sarwal, Aarti	United States	North Carolina	Winston-Salem
80	University of Colorado Hospital	Poisson, Sharon	United States	Colorado	Aurora
81	University of California Davis Health System	Ng, Kwan	United States	California	Sacramento
82	UCSD Health- La Jolla	Meyer, Brett	United States	California	La Jolla
83	University of New Mexico	Torbey, Michel	United States	New Mexico	Albuquerque
84	Summa Health System	Bowling, Susana	United States	Ohio	Akron
85	University Hospital and UW Health Clinics	Elliott, Jamie	United States	Wisconsin	Madison
86	Miami Valley Hospital South	Terry, John	United States	Ohio	Dayton
87	St.David's HealthCare Office of Research	Pulido, Angel	United States	Texas	Austin
88	Cone Health	Xu, Jindong	United States	North Carolina	Greensboro
89	TriStar Skyline Medical Center	Witt, John	United States	Tennessee	Nashville
90	PsychCare Consultants Research	Malik, Maheen	United States	Missouri	St. Louis
91	Washington University Physicians	Diringer, Michael	United States	Missouri	St. Louis
92	Sinai Hospital of Baltimore	Berkeley, Jennifer	United States	Maryland	Baltimore
93	University of Buffalo	Ching, Marilou	United States	New York	Buffalo
94	University of Tennessee Health Sciences Center	Alexandrov, Andrei	United States	Tennessee	Memphis
95	Royal Melbourne Hospital	Campbell, Bruce	Australia	Victoria	Parkville
96	The Alfred Hospital	Cloud, Geoffrey	Australia	Victoria	Melbourne
97	Monash Medical Centre	Phan, Thanh	Australia	Victoria	Clayton
98	Liverpool Hospital	Cordato, Dennis	Australia	New South Wales	Liverpool
99	Princess Alexandra Hospital	Brown, Helen	Australia	Queensland	Woolloongabba
100	Sunshine Hospital	Wijeratne, Tissa	Australia	Victoria	St Albans
101	Royal North Shore Hospital	Krause, Martin	Australia	New South Wales	St Leonards
102	John Hunter Hospital	Esperon, Carlos	Australia	New South Wales	New Lambton Heights
103	Royal Adelaide Hospital	Kleinig, Timothy	Australia	South Australia	Adelaide
104	武汉大学人民医院	卢祖能	中国	湖北省	武汉市
105	东南大学附属中大医院	闫福岭	中国	江苏省	南京市
106	浙江大学医学院附属邵逸夫医院	胡兴越	中国	浙江省	杭州市
107	The Cleveland Clinic Foundation	Gomes, Joao	United States	Ohio	Cleveland
108	Clinique CHC MontLégia	Desfontaines, Philippe	Belgium	N/A	Liege
109	Universitair Ziekenhuis Gent	Hemelsoet, Dimitri	Belgium	N/A	Gent
110	UZ Leuven	Lemmens, Robin	Belgium	N/A	Leuven
111	Hospital das Clínicas FMRP-USP	Marques Pontes Neto, Octávio	Brazil	Sao Paulo	Ribeirao Preto
112	Hospital de Clínicas de Porto Alegre	Ouriques Martins, Sheila Cristina	Brazil	Rio Grande do Sul	Porto Alegre
113	Hospital Sao Paulo	Sampaio Silva, Gisele	Brazil	Sao Paulo	Sao Paulo
114	Clinica Neurológica e Neurocirúrgica de Joinville	Cabral Moro, Carla Heloísa	Brazil	Santa Catarina	Joinville
115	HGF - Hospital Geral de Fortaleza	Martins Maia Carvalho, Fernanda	Brazil	Ceará	Fortaleza
116	University of Alberta Hospital	Shuaib, Ashfaq	Canada	Alberta	Edmonton
117	Foothills Medical Centre	Demchuk, Andrew	Canada	Alberta	Calgary
118	Fakultni nemocnice Ostrava	Bar, Michal	Czech Republic	N/A	Ostrava-Poruba
119	Fakultni nemocnice Hradec Kralove	Herzig, Roman	Czech Republic	N/A	Hradec Kralove
120	Fakultni nemocnice u sv. Anny v Brne	Mikulik, Robert	Czech Republic	N/A	Brno
121	Fakultni nemocnice Kralovske Vinohrady	Stetkarova, Ivana	Czech Republic	N/A	Praha
122	Fakultni nemocnice v Motole	Tomek, Ales	Czech Republic	N/A	Praha 5
123	Fakultni nemocnice Brno	Skorna, Miroslav	Czech Republic	N/A	Brno
124	Hopital Roger Salengro - CHU Lille	Henon, Hilde	France	Nord	Lille Cedex
125	CHU Nantes - Hopital Nord Laennec	Guillon, Benoit	France	Loire Atlantique	Nantes cedex 1
126	CHU Besancon - Hopital Jean Minjoz	Moulin, Thierry	France	Doubs	Besancon Cedex
127	Groupe Hospitalier Pellegrin - Hopital Pellegrin	Sibon, Igor	France	Gironde	Bordeaux Cedex
128	CHU de Brest - Hopital de la Cavale Blanche	Timsit, Serge	France	Finistere	Brest cedex 2
129	CHU CAEN - Hopital de la Cote de Nacre	Cogez, Julien	France	Calvados	Caen cedex 9
130	CHU Rennes - Hopital Pontchaillou	Vannier, Stéphane	France	Ille et Vilaine	Rennes
131	CHU Nancy - Hopital Central	Richard, Sébastien	France	Meurthe et Moselle	Nancy
132	Groupement Hospitalier Sud - Hopital Bicêtre	Denier, Christian	France	Val de Marne	Le Kremlin Bicêtre cedex
133	Universitaetsklinikum Carl Gustav Carus TU Dresden	Barlinn, Kristian	Germany	Dresden	Dresden
134	Klinikum Altenburger Land GmbH	Berrouschot, Joerg	Germany	Thueringen	Altenburg
135	Universitaetsklinikum Essen	Koehrmann, Martin	Germany	Nordrhein Westfalen	Essen
136	Universitaetsklinikum Freiburg	Niesen, Wolf-Dirk	Germany	Baden Wuerttemberg	Freiburg
137	Klinikum der Johann Wolfgang Goethe-Universitaet	Pfeilschifter, Waltraud	Germany	Hessen	Frankfurt
138	Klinikum Augsburg	Schneider, Hauke	Germany	Bayern	Augsburg
139	Klinikum Frankfurt Hoechst GmbH	Steiner, Thorsten	Germany	Hessen	Frankfurt
140	Klinikum Kassel GmbH	Boesel, Julian	Germany	Hessen	Kassel
141	Universitaetsklinikum Muenster	Minnerup, Jens	Germany	Nordrhein Westfalen	Muenster
142	Universitaetsklinikum Erlangen	Kallmuenzer, Bernd	Germany	Bayern	Erlangen
143	Rhon-Klnikum Campus Bad Neustadt	Soda, Hassan	Germany	Bayern	Bad Neustadt Saale
144	Semmelweis Egyetem	Bereczki, Daniel	Hungary	N/A	Budapest
145	SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz	Dioszeghy, Peter	Hungary	N/A	Nyiregyhaza
146	Pest Megyei Flor Ferenc Korhaz	Panczel, Gyula	Hungary	N/A	Kistarcsa
147	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Vecsei, Laszlo	Hungary	N/A	Szeged
148	Petz Aladar Megyei Oktato Korhaz	Csanyi, Attila	Hungary	N/A	Gyor
149	Somogy Megyei Kaposi Mor Oktato Korhaz	Radai, Ferenc	Hungary	N/A	Kaposvar
150	Shaare Zedek Medical Center	Eichel, Roni	Israel	N/A	Jerusalem
151	Soroka University Medical Center	Horev, Anat	Israel	N/A	Beer Sheva
152	Rambam Health Care Center	Telman, Gregory	Israel	N/A	Haifa
153	Tel Aviv Sourasky Medical Center	Hallevi, Hen	Israel	N/A	Tel Aviv
154	Rabin MC	Peretz, Shlomi	Israel	N/A	Petah Tikva
155	Hadassah University Hospital - Ein Kerem	Leker, Ronen	Israel	N/A	Jerusalem.
156	Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza	Toni, Danilo	Italy	Roma	Rome
157	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Diomedi, Marina	Italy	Roma	Rome
158	Azienda Ospedaliero Universitaria San Martino	Finocchi, Cinzia	Italy	Genova	Genova
159	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)	Magoni, Mauro	Italy	Brescia	Brescia
160	Ospedale San Raffaele	Roveri, Luisa	Italy	Milano	Milano
161	A.O.U. Senese Policlinico Santa Maria alle Scotte	Tassi, Rosanna	Italy	Siena	Siena
162	Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)	Agostoni, Elio Clemente	Italy	Milano	Milano
163	Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza	Rasura, Maurizia	Italy	Roma	Roma
164	Azienda Ospedaliera Universitaria Careggi	Nencini, Patrizia	Italy	Firenze	Firenze
165	Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico	Bonato, Sara	Italy	Milano	Milano
166	Istituto Clinico Humanitas	Marcheselli, Simona	Italy	Milano	Rozzano
167	Asahikawa Red Cross Hospital	Takizawa, Katsumi	Japan	Hokkaido	Asahikawa-shi
168	Nippon Medical School Hospital	Kimura, Kazumi	Japan	Tokyo-To	Bunkyo-ku
169	Kobe City Hospital Organization Kobe City Medical Center General Hospital	Sakai, Nobuyuki	Japan	Hyogo-Ken	Kobe-shi
170	Southern Tohoku General Hospital	Kaneko, Chikako	Japan	Fukushima-Ken	Koriyama-shi
171	Kimitsu Chuo Hospital	Hayasaka, Michihiro	Japan	Chiba-Ken	Kisarazu-shi
172	National Cerebral and Cardiovascular Center	Koga, Masatoshi	Japan	Osaka-Fu	Suita-shi
173	Kurashiki Central Hospital	Chin, Masaki	Japan	Okayama-Ken	Kurashiki-shi
174	NHO Kyushu Medical Center	Yasaka, Masahiro	Japan	Fukuoka-Ken	Fukuoka-shi
175	Kyorin University Hospital	Hirano, Teruyuki	Japan	Tokyo-To	Mitaka-shi
176	Iwate Prefectural Central Hospital	Kimura, Naoto	Japan	Iwate-Ken	Morioka-shi
177	Saitama Medical University International Medical Center	Takahashi, Shinichi	Japan	Saitama-Ken	Hidaka-shi
178	Tokyo Metropolitan Tama Medical Center	Ueda, Masayuki	Japan	Tokyo-To	Fuchu-shi
179	Tsuchiura Kyodo General Hospital	Machida, Akira	Japan	Ibaraki-Ken	Tsuchiura-shi
180	Rinku General Medical Center	Hagihara, Yasushi	Japan	Osaka-Fu	Izumisano-shi
181	Showakai Brain Attack Center Ota Memorial Hospital	Sato, Kota	Japan	Hiroshima-Ken	Fukuyama-shi
182	Ohnishi Neurological Center	Kuga, Yoshihiro	Japan	Hyogo-Ken	Akashi-shi
183	Hachinohe Red Cross Hospital	Konno, Hiromu	Japan	Aomori-Ken	Hachinohe-shi
184	NHO Minami Wakayama Medical Center	Kawabata, Masayuki	Japan	Wakayama-Ken	Tanabe-shi
185	Gifu Prefectural General Medical Center	Kumagai, Morio	Japan	Gifu-Ken	Gifu-shi
186	Yamanashi Prefectural Central Hospital	Nakano, Shin	Japan	Yamanashi-Ken	Kofu-shi
187	Seoul National University Bundang Hospital	Han, Moon-Ku	Korea, Republic of	Gyeonggi-do	Seongnam-si
188	Dong-A University Hospital	Jeong, Jin-Heon	Korea, Republic of	N/A	Pusan
189	Asan Medical Center	Jeon, Sang-Beom	Korea, Republic of	N/A	Seoul
190	Kyungpook National University Hospital	Hwang, Yangha	Korea, Republic of	Gyeongsangnam-do	Daegu
191	Centro Hospitalar e Universitário de Coimbra E.P.E - Hospitais da Universidade de Coimbra	Santo, Gustavo	Portugal	N/A	Coimbra
192	Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)	Tedim Cruz, Vitor	Portugal	N/A	Matosinhos
193	Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria	Pinho e Melo, Teresa	Portugal	N/A	Lisboa
194	Hospital Garcia de Orta, EPE	Rodrigues, Miguel	Portugal	N/A	Almada
195	Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de S？o Sebasti？o	Roriz, José Mário	Portugal	N/A	Santa Maria da Feira
196	Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz	Viana Baptista, Miguel	Portugal	N/A	Lisboa
197	SBEI HPE	Bogdanov, Enver	Russian Federation	N/A	Kazan
198	SBIH of Moscow	Lebedeva, Anna	Russian Federation	N/A	Moscow
199	SPb SBIH	Melnikova, Elena	Russian Federation	N/A	Saint-Petersburg
200	Saint-Petersburg Scientific-Research Institute of Emergency Care	Voznyuk, Igor	Russian Federation	N/A	Saint-Petersburg
201	Hospital Clinico Universitario de Valladolid	Arenillas Lara, Juan Francisco	Spain	Valladolid	Valladolid
202	Hospital Universitari de Bellvitge	Cardona Portela, Pedro	Spain	Barcelona	L'Hospitalet de Llobregat
203	Hospital Universitari i Politecnic La Fe	Fortea Cabo, Gerardo	Spain	Valencia	Valencia
204	Hospital Universitario Ramon y Cajal	Masjuan Vallejo, Jaime	Spain	Madrid	Madrid
205	Hospital Universitario Virgen del Rocio	Moniche Alvarez, Francisco	Spain	Sevilla	Sevilla
206	Hospital Universitari Vall d'Hebron	Molina Cateriano, Carlos	Spain	Barcelona	Barcelona
207	Hospital del Mar	Rodriguez Campello, Ana	Spain	Barcelona	Barcelona
208	Hospital Regional Universitario de Malaga	Bustamante, Rafael	Spain	Málaga	Malaga
209	Hospital Universitario Virgen Macarena	Gamero Garcia, Miguel Angel	Spain	Sevilla	SEVILLA
210	Complejo Hospitalario Universitario de Santiago	Arias Rivas, Susana	Spain	La Coruna	Santiago de Compostela
211	Hospital Universitari de Girona Dr Josep Trueta	Serena Leal, Joaquin	Spain	Girona	Girona
212	Hospital Universitario Reina Sofia	Agüera Morales, Eduardo	Spain	Córdoba	Cordoba
213	Inselspital - Universitaetsspital Bern	Arnold, Marcel	Switzerland	N/A	Bern
214	Ospedale Regionale di Lugano	Cereda, Carlo	Switzerland	N/A	Lugano
215	Newcastle University- Clinical Ageing Research Unit	Dixit, Anand	United Kingdom	Tyne & Wear	Newcastle upon Tyne
216	Charing Cross Hospital	Halse, Omid	United Kingdom	Greater London	London
217	Queen Elizabeth University Hospital Campus	Muir, Keith	United Kingdom	Strathclyde	Glasgow
218	Nottingham University Hospitals City Campus	Sprigg, Nikola	United Kingdom	Nottinghamshire	Nottingham
219	Kings College Hospital NHS Foundation Trust	Sztriha, Laszlo	United Kingdom	Greater London	London
220	Addenbrooke's Hospital	Zachariah, George	United Kingdom	Cambridgeshire	Cambridge
221	The National Hospital for Neurology & Neurosurgery	Perry, Richard	United Kingdom	Greater London	London
222	Helsinki University Hospital	Strbian, Daniel	Finland	N/A	HUS
223	Turun yliopistollinen keskussairaala	Ruuskanen, Jori	Finland	N/A	Turku
224	Kaohsiung Chang Gung Memorial Hospital	Chang, Chiung-Chih	Taiwan, Republic of China	N/A	Kaohsiung
225	National Cheng Kung University Hospital	Chen, Chih-Hung	Taiwan, Republic of China	N/A	Tainan
226	National Taiwan University Hospital	Tang, Sung-Chun	Taiwan, Republic of China	N/A	Taipei
227	Chang Gung Memorial Hospital, Linkou	Lee, Tsong-Hai	Taiwan, Republic of China	N/A	Taoyuan County
228	Bispebjerg og Frederiksberg Hospital	Christensen, Hanne	Denmark	N/A	Copenhagen NV
229	Copenhagen University Hospital and Glostrup Hospital	Iversen, Helle	Denmark	N/A	Glostrup
230	Sjaellands Universitetshospital	Wienecke, Troels	Denmark	N/A	Roskilde
231	St. Marianna University School of Medicine Hospital	Yamano, Yoshihisa	Japan	Kanagawa-Ken	Kawasaki-shi
232	Chiyukai Fukuoka Shinmizumaki Hospital	Kin, Shigenari	Japan	Fukuoka-Ken	Onga-gun
233	Toyota Memorial Hospital	Ito, Yasuhiro	Japan	Aichi-Ken	Toyota-shi
234	Yamaguchi University Hospital	Nomura, Sadahiro	Japan	Yamaguchi-Ken	Ube-shi
235	Chiyukai Shin Yukuhashi Hospital	Akaike, Yuji	Japan	Fukuoka-Ken	Yukuhashi-shi
236	NHO Sendai Medical Center	Ezura, Masayuki	Japan	Miyagi-Ken	Sendai-shi
237	Okayama City General Medical Center Okayama City Hospital	Tokunaga, Koji	Japan	Okayama-Ken	Okayama-shi
238	Chiyukai Fukuoka Wajiro Hospital	Fukuyama, Kozo	Japan	Fukuoka-Ken	Fukuoka-shi
239	General Hospital Varazdin	Kidjemet-Piskac, Spomenka	Croatia	N/A	Varazdin
240	Clinical Hospital Centar Zagreb	Poljakovic, Zdravka	Croatia	N/A	Zagreb
241	Clinical Hospital	Roje Bedekovic, Marina	Croatia	N/A	Zagreb
242	Vilnius University Hospital Santariskiu Clinic, Public Institution	Jatuzis, Dalius	Lithuania	N/A	Vilnius
243	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Matijosaitis, Vaidas	Lithuania	N/A	Kaunas
244	Republican Vilnius University Hospital, Public Institution	Vilionskis, Aleksandras	Lithuania	N/A	Vilnius

1	有能力理解本研究的目的和风险，在知情同意书上签字并注明日期，授权根据国家和当地受试者隐私法规使用机密健康信息，或者当地法规允许时可由一名独立医师提供知情同意，和/或可由受试者的法定授权代表(LAR)根据所有当地和国家法规，或根据当地伦理委员会指南，或适用的国家法律和法规以及伦理委员会要求的其他程序提供知情同意。
2	临床诊断为MCA供血区域内急性缺血性脑卒中（除了主要MCA供血区域卒中以外，累及PCA和/或ACA供血区域亦可接受）。
3	提供知情同意时的年龄为18-85岁（含）（在中国年龄为18-70岁）。
4	筛选时NIHSS大于或等于10。
5	研究者认为发生该次脑卒中之前并无重大残疾（无需看护、配偶或他人协助即能够独立履行所有职责及从事日常活动）。
6	按照优先顺序，大面积脑梗死定义为：a) 磁共振成像(MRI)弥散加权成像(DWI)获得的病灶体积为80-300 cm3，或者b) 计算机断层灌注成像(CTP)获得的核心病灶体积为80-300 cm3，或者c) 如果利用MRI DWI或CTP获得的病灶体积不可用，利用非对比增强计算机断层扫描(NCCT)获得的Alberta卒中项目早期计算机断层扫描(CT)评分(ASPECTS)为1-5，并累及至少2个规定的皮层区域。如果某特定受试者有一个以上扫描结果不一致，研究者应在考虑所有患者信息的基础上作出合格性判断，这些信息包括但不限于：1）扫描时间和2）研究者认为最能反映梗死尺寸的扫描模式。合格性判断所用的扫描将加以记录。注：应尽可能使用自动化影像分析软件作为标准方法，以协助估计梗死核心体积和/或ASPECTS。将由研究者或当地读片人最终确定ASPECTS，评估入选资格。如果SOC中未纳入适当的基线扫描，则将进行研究专用MRI DWI、CTP或NCCT（按此优先顺序）。如果认为适当且可在输注前实现，可出于研究入选目的重复实施扫描。
7	对于随机化之前接受机械取栓术的受试者来说，入选研究的基本条件必须为机械取栓术后经MRI-DWI测定梗死体积为80-300 cm3。
8	应在症状发作后尽快启动研究药物治疗输注，不得迟于症状发作后10小时（如果已知症状发作时间），或最后一次已知正常的时间后10小时（如果症状发作的时间未知）。

1	研究者判断，受试者可能在第一天终止支持治疗。
2	入组前承诺接受去骨瓣减压术(DC)。
3	研究者认为有对侧半球并发梗死的证据（临床或影像），病变严重到足以影响功能结局。例如，对侧ACA梗死导致双腿麻痹。
4	存在脑疝形成的临床体征，例如，1侧或2侧瞳孔扩大、固定；脑水肿相关的意识丧失（即，NIHSS项目1a评分大于或等于2）；和/或研究者判断由脑水肿或脑疝形成引起的其他脑干反射丧失。
5	NCCT/MRI发现存在脑出血（不包括小瘀斑/点状出血）。
6	入组前NCCT/MRI表明存在前间隔/松果体偏移大于2 mm的证据。
7	使用了动脉内溶栓剂，单独使用或结合机械取栓术。
8	除依达拉奉外，本次脑卒中发作后7天内计划使用任何神经保护剂（包括但不限于DL-3-正丁基苯酞[NBP]和七叶皂苷钠）。
9	本次脑卒中发作后7天内不愿意/无法停用中药的受试者。
10	目前考虑接受机械取栓术和/或静脉溶栓治疗的患者，只有待这些手术结束之后或者作出不实施手术的决定之后，方可随机进入本研究。不得由于研究筛选程序而延迟这些治疗。如果在随机化前接受了机械取栓术，则必须使用入选标准#7评估研究入选合格性。
11	研究者认为非当前LHI病情导致的预期寿命小于3个月的受试者，或者不太可能遵循随访的受试者。
12	受试者不能放置外周静脉通路。
13	受试者具有精神残疾（确诊LHI前）或受国家监护。
14	受试者的脑卒中症状迅速好转，且研究者认为随机化时其无法达到NIHSS大于或等于10。
15	已知对BIIB093或另一种磺酰脲类降糖药物或BIIB093制剂或匹配安慰剂的任何成分过敏。
16	已知受试者在过去10小时内口服过格列本脲。
17	研究者认为已知受试者有具有临床意义的重度肾病或肝病史（例如，透析或肝硬化）。
18	研究者认为已知受试者有重度（例如，需要家庭输氧）慢性阻塞性肺病史。
19	基于已知病史或当地实验室筛选评估结果（即，筛选血糖低于70 mg/dL [约3.9 mmol/L]），研究者认为已知受试者存在具有临床意义的低血糖史。
20	受试者发生或者曾经发生过糖尿病酮症酸中毒或糖尿病性昏迷/前驱昏迷。
21	过去3个月内，发生了急性ST段抬高型心肌梗塞(MI)，和/或急性失代偿性心力衰竭，和/或QTc大于520毫秒，和/或因急性冠脉综合征、MI、心脏骤停住院治疗或非自愿性冠脉干预治疗（经皮冠状动脉介入治疗或冠状动脉手术）。
22	纽约心脏病协会心力衰竭III/IV级（III级：由于症状导致活动明显受限，即使轻微活动亦受限，例如短距离行走（20-100 m）；IV级：重度限制。甚至静息时亦存在症状。多数为卧床患者）。
23	已知存在室性心动过速。
24	已知葡萄糖-6-磷酸脱氢酶缺乏症受试者。
25	研究者认为，筛选前3天内，受试者发生了需要住院治疗或具有临床意义的严重局部感染（例如，蜂窝组织炎，脓肿）或全身性感染（例如，败血症）。
26	入组时处于妊娠期的女性，或妊娠试验结果为阳性的育龄女性。
27	研究治疗输注期间和研究治疗输注结束后7天内不能终止哺乳的哺乳期女性。
28	入组前14天内已知当时正参与或已知曾经参与其他涉及某种试验用药物的试验性研究。
29	无法遵循研究要求。
30	研究者或Biogen认为受试者因其他未说明的理由而不适合参与本研究。

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