San Donato Milanese利伐沙班片III期临床试验-利伐沙班预防计划行心脏复律非瓣膜性心房纤颤患者研究

登记号	CTR20132867	试验状态	已完成
申请人联系人	临床试验信息公布组	首次公示信息日期	2014-05-19
申请人名称	Bayer Pharma AG/ 拜耳医药保健有限公司

登记号	CTR20132867
相关登记号	暂无
药物名称	利伐沙班片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	心房颤动
试验专业题目	比较利伐沙班与VKA在计划行心脏复律的非瓣膜性房颤患者中预防心血管事件的有效性和安全性的一项研究
试验通俗题目	利伐沙班预防计划行心脏复律非瓣膜性心房纤颤患者研究
试验方案编号	15693	方案最新版本号	暂无
版本日期:	暂无	方案是否为联合用药	企业选择不公示

申请人名称	1 2
联系人姓名	临床试验信息公布组	联系人座机	010 65360866	联系人手机号	暂无
联系人Email	clinical-trials-contact@bayer.com	联系人邮政地址	北京市朝阳区东三环北路27号嘉铭中心B座18层	联系人邮编	100020

伴有异常心脏节律（心房纤颤）的患者计划进行心脏复律（使恢复正常心脏节律的操作）。此研究会比较患者随机（像投硬币一样）分配到利伐沙班组或维生素K拮抗剂（VKA）组。此研究会测量普通医学事件结果如出血或卒中。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	1 年龄≥18岁的男性或女性 2 血流动力学稳定的非瓣膜性房颤持续超过48小时或持续时间未知 3 计划进行非瓣膜性房颤的心脏复律（电复律或药物复律） 4 有生育可能的女性和男性必须同意在性行为时使用充分的避孕措施
排除标准	1 在随机化访视前3个月内有重度、致残性卒中（改良Rankin评分4–5分，含4和5分）或随机化访视前14天内有任何卒中 2 在随机化前3天内有短暂性缺血发作 3 在随机化前14天内有急性血栓栓塞事件或血栓（静脉/动脉）形成 4 在随机化前14天内有急性心肌梗死 5 心脏相关标准: 已知存在源性血栓或粘液瘤或瓣膜性房颤 6 抗凝剂治疗禁忌：活跃出血或高出血风险 7 合并用药：除房颤之外其他适用于抗凝治疗的疾病、长期阿司匹林治疗>100mg/天或双重抗血小板治疗、全身使用细胞色素P450（CYP）-3A4和P–糖蛋白（P-gp）的强抑制剂 8 伴发情况：有生育可能但未采用正确的避孕措施、妊娠或哺乳、对研究药物治疗或对照药物治疗过敏、计算得出肌酐清除率(CrCl) 9 对照药物治疗或试验药物治疗的当地说明书中所列的任何其他禁忌症 10 在随机化前30天内参加过研究性药物或医疗器械的研究

试验药	序号 名称 用法 1 中文通用名:利伐沙班(拜瑞妥,BAY59-7939) 用法用量:剂型：片剂规格：15mg/20mg给药途径：口服用药频次：1次/天剂量：15mg/20mg用药时程：对于采用直接复律策略的患者，应在随机化后1–5天内进行心脏复律。利伐沙班或VKA在计划直接复律前给药1–5天，复律后给药42天。
对照药	序号 名称 用法 1 中文通用名:维生素K拮抗剂(VKA) 用法用量:剂型：片剂规格：医生根据当地诊疗常规提供VKA给药途径：口服用药频次：1次/天剂量：根据INR调整用药时程：对于采用直接复律策略的患者，应在随机化后1–5天内进行心脏复律。利伐沙班或VKA在计划直接复律前给药1–5天，复律后给药42天。

主要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 以下事件的复合数量，由中心评估：卒中、短暂性脑缺血发作（TIA）、非中枢神经系统（CNS）全身性栓塞、心肌梗死（MI）和心血管死亡 最多100天 有效性指标 2 大出血事件的数量，由中心评估 最多100天 有效性指标
次要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 卒中及非CNS全身性栓塞复合数量 最多100天 有效性指标 2 卒中、短暂性脑缺血发作、非CNS全身性栓塞、心肌梗死及全因死亡的复合数量 最多100天 有效性指标 3 卒中数量 最多100天 有效性指标 4 短暂性脑缺血发作数量 最多100天 有效性指标 5 非CNS全身性栓塞数量 最多100天 有效性指标 6 心肌梗死数量 最多100天 有效性指标 7 心血管死亡数量 最多100天 有效性指标 8 大出血和非大出血复合数量 最多100天 安全性指标

1	姓名	Ricardo Cappato	学位	暂无	职称	教授
	电话	390252774337	Email	riccardo.cappato@grupposandonato.it	邮政地址	Center of Clinical Arrythmia & Electrophysiology, I.R.C.C.S. Policlinico San Donato, Via Morandi
	邮编	20097	单位名称	Center of Clinical Arrythmia & Electrophysiology, I.R.C.C.S. Policlinico San Donato, Via Morandi

序号	机构名称	主要研究者	国家	省（州）	城市
1	Gruppo Ospedaliero San Donato Foundation	Ricardo Cappato	Italy	Milano	San Donato Milanese
2	Hospital Erasme/Erasmus Ziekenhuis	Philippe VAN DE BORNE	Belgium	BRUXELLES - BRUSSEL	BRUXELLES - BRUSSEL
3	Jessa Ziekenhuis	Johan VIJGEN	Belgium	HASSELT	HASSELT
4	CHR de la Citadelle	Eti？nne HOFFER	Belgium	LIEGE	LIEGE
5	H. Hartziekenhuis Mol	Harry STRIEKWOLD	Belgium	MOL	MOL
6	Grand H？pital de Charleroi	Jean LEROY	Belgium	GILLY	GILLY
7	Hospital Universitário Evangélico de Curitiba	Paulo Roberto Rossi	Brazil	Paraná	Curitiba
8	Loema Instituto de Pesquisa Clinica & Consultores LTDA	Fabio Santos	Brazil	S？o Paulo	Campinas
9	Pontificia Universidade Católica do RS - Centro Clínico	Carlos Ant？nio Kalil	Brazil	Rio Grande do Sul	Porto Alegre
10	Hospital das Clínicas da Faculdade de Medicina da USP	Mauricio Scanavacca	Brazil	Soeo Paulo	Sao Paulo
11	PUC Campinas - Hospital e Maternidade Celso Pierro	José Saraiva	Brazil	Soeo Paulo	Campinas
12	Montreal Heart Institute	Mario Talajic	Canada	Quebec	Montreal
13	Saint John Regional Hospital	Gregory Searles	Canada	New Brunswick	Saint John
14	Hopital Laval	Gilles O'Hara	Canada	Quebec	Quebec
15	Royal Alexandra Hospital	Evan Lockwood	Canada	Alberta	Edmonton
16	St. Michael's Hospital Health Centre	Iqwal Mangat	Canada	Ontario	Toronto
17	Hamilton General Hospital	Stuart Connolly	Canada	Ontario	Hamilton
18	CHUM - Hopital Hotel-Dieu	Benoit Coutu	Canada	Quebec	Montreal
19	Victoria Cardiac Arrhythmia Trails, Inc.	Laurence Sterns	Canada	British Columbia	Victoria
20	Health Sciences Centre - Eastern Health	Sean Connors	Canada	Newfoundland and Labrador	St. John's
21	首都医科大学附属北京安贞医院	马长生	中国	北京	北京
22	西安交通大学医学院第一附属医院	袁祖贻	中国	陕西	西安
23	沈阳军区总医院	王祖禄	中国	辽宁	沈阳
24	武汉亚洲心脏病医院	苏晞	中国	湖北	武汉
25	新疆医科大学第一附属医院	汤宝鹏	中国	新疆	乌鲁木齐
26	中南大学湘雅二医院	刘启明	中国	湖南	长沙
27	广东省人民医院	吴书林	中国	广东	广州
28	南昌大学第二附属医院	洪葵	中国	江西	南昌
29	吉林大学第一医院	郑杨	中国	吉林	长春
30	Regionshospitalet Viborg, Skive, Kjellerup	Jens Refsgaard	Denmark	Viborg	Viborg
31	Regionshospitalet Herning	Ole May	Denmark	Herning	Herning
32	Gentofte Hospital	Gunner Gislason	Denmark	Hellerup	Hellerup
33	H:S Bispebjerg Hospital	Henrik Nielsen	Denmark	Kobenhavn NV	Kobenhavn NV
34	Turun yliopistollinen keskussairaala, kantasairaala	Juhani Airaksinen	Finland	Turku	Turku
35	Etelo -Karjalan keskussairaala	Seppo Utriainen	Finland	Lappeenranta	Lappeenranta
36	Satakunnan keskussairaala	Tuomas Paana	Finland	Pori	Pori
37	Keski-Suomen keskussairaala	Pirjo Mustonen	Finland	Jyvo skylo	Jyvo skylo
38	Lapin keskussairaala	Alexandre Hadjikov	Finland	Rovaniemi	Rovaniemi
39	Oulun yliopisto	Heikki Huikuri	Finland	Oulu	Oulu
40	Vaasan keskussairaala	Juhani Koistinen	Finland	Vaasa	Vaasa
41	Tampereen yliopistollinen sairaala, keskussairaala	Pekka Raatikainen	Finland	Tampere	Tampere
42	HUS, Meilahden sairaala	Mika Lehto	Finland	Helsinki	Helsinki
43	Hospital Cardiologique - Lille Cedex	salem Kacet	France	LILLE CEDEX	LILLE CEDEX
44	Centre Hospitalier - Arras	Abed RIFAI	France	ARRAS	ARRAS
45	Hopital Bichat - Paris	Antoine Leenhardt	France	PARIS	PARIS
46	Institut de cardiologie/Salpétrière	Richard ISNARD	France	Paris cedex 13	Paris cedex 13
47	Hospital Cardiologique - Pessac	Frederic Sacher	France	PESSAC	PESSAC
48	Hospital de Rangueil - Toulouse	Meyer ELBAZ	France	TOULOUSE cedex	TOULOUSE cedex
49	Centre Hospitalier Universitaire Brabois	Etienne ALIOT	France	VANDOEUVRE-LES-NANCY	VANDOEUVRE-LES-NANCY
50	H？pital Trousseau - Tours	Laurent FAUCHIER	France	TOURS	TOURS
51	Hopital Saint Antoine - Paris	Stéphane EDERHY	France	PARIS	PARIS
52	Klinikum der Johann Wolfgang Goethe Universit？t Frankfurt	Stefan Hohnloser	Germany	Hessen	Frankfurt
53	Kliniken Maria Hilf GmbH	Jürgen vom Dahl	Germany	Nordrhein-Westfalen	Monchengladbach
54	Charité Campus Virchow-Klinikum (CVK)	Wilhelm Haverkamp	Germany	Berlin	Berlin
55	Universitytsklinikum Essen	Peter Krings	Germany	Nordrhein-Westfalen	Essen
56	University tsklinikum Hamburg Eppendorf (UKE)	Stephan Willems	Germany	Hamburg	Hamburg
57	Universitytsklinikum Freiburg	Thomas Faber	Germany	Baden-Württemberg	Freiburg
58	Herz- und Diabeteszentrum Nordrhein-Westfalen	Cornelia Piper	Germany	Nordrhein-Westfalen	Bad Oeynhausen
59	Krankenhaus Dresden-Friedrichstadt	Sebastian Schellong	Germany	Sachsen	Dresden
60	Kliniken Nord und Süd	Dirk Bastian	Germany	Bayern	Nürnberg
61	University tsklinikum Leipzig A？R	Andreas Bollmann	Germany	Sachsen	Leipzig
62	Johannes-Gutenberg-Universit？t Mainz	Tommaso Gori	Germany	Rheinland-Pfalz	Rheinland-Pfalz
63	University General Hospital of Heraklion	Panagiotis Vardas	Greece	Heraklion	Heraklion
64	Hippokration General Hospital of Thessaloniki	Vassilios Vassilikos	Greece	Thessaloniki	Thessaloniki
65	University General Hospital of Alexandroupolis	Dimitrios Tziakas	Greece	Alexandroupolis	Alexandroupolis
66	Henry Dunant Hospital	George Andrikopoulos	Greece	Attica / Athens	Attica / Athens
67	ARNAS Garibaldi	Michele Massimo Gulizia	Italy	Catania	Catania
68	A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi	Alessandro Capucci	Italy	Ancona	Ancona
69	A.O. Sant'Anna	Giovanni Luca Botto	Italy	Como	San Fermo della Battaglia
70	Ente Ecclesiastico Ospedale Generale Regionale Miulli	Massimo Grimaldi	Italy	Bari	Acquaviva delle Fonti
71	AULSS 12 Veneziana - Veneto	Sakis Themistoclakis	Italy	Venezia	Venezia
72	A.O. Città della Salute e della Scienza di Torino	Fiorenzo Gaita	Italy	Torino	Torino
73	ASL RM/B Roma - Lazio	Leonardo Calò	Italy	Roma	Roma
74	Atrium Medisch Centrum Parkstad	J.A. Kragten	Netherlands	HEERLEN	HEERLEN
75	Academisch Ziekenhuis Maastricht	H.J.G.M. Crijns	Netherlands	MAASTRICHT	MAASTRICHT
76	Medisch Centrum Leeuwarden	R.W. Breedveld	Netherlands	LEEUWARDEN	LEEUWARDEN
77	Ziekenhuis Rijnstate	M. Hemels	Netherlands	ARNHEM	ARNHEM
78	Kennemer Gasthuis, Locatie Zuid	R. Tukkie	Netherlands	HAARLEM	HAARLEM
79	Centro Hospitalar Vila Nova de Gaia	Joeo Primo	Portugal	Vila Nova de Gaia	Vila Nova de Gaia
80	Centro Hospitalar de Lisboa Central-Hospital Santa Marta	Mário Oliveira	Portugal	Lisboa	Lisboa
81	Hospital Garcia da Orta	Luis Brand？o	Portugal	Almada	Almada
82	Centro Hospitalar de Lisboa Ocidental, EPE - H.Santa Cruz	Pedro Pedro Adrago	Portugal	Lisboa	Carnaxide
83	Hospital Distrital de Faro	Walter Santos	Portugal	Faro	Faro
84	Centro Hospitalar Universitario de Coimbra - H. Dos Cov？es	Paula Mota	Portugal	Coimbra	Martinho do Bispo
85	National Heart Centre	Tan Ru San	Singapore	Singapore	Singapore
86	Tan Tock Seng Hospital	David Foo	Singapore	Singapore	Singapore
87	Khoo Teck Puat Hospital	Hean Yee Ong	Singapore	Singapore	Singapore
88	National University Hospital	Swee-Chong Seow	Singapore	Singapore	Singapore
89	Kuils River Hospital	Jan Saaiman	South Africa	Western Cape	Kuils River
90	Clinical Projects Research SA	Louis van Zyl	South Africa	Western Cape	Worcester
91	IATROS	Abraham Barnard	South Africa	Bloemfontein	Bloemfontein
92	Vincent Pallotti Hospital	Adrian Horak	South Africa	Western Cape	Cape Town
93	University of Stellenbosch	Henry Cyster	South Africa	Western Cape	Cape Town
94	Vincent Pallotti Hospital	Saleem Dawood	South Africa	Western Cape	Cape Town
95	Chris Hani Baragwanath Hospital	Mohammed Essop	South Africa	Gauteng	SOWETO
96	Vergelegen Medi-Clinic	Johan Engelbrecht	South Africa	Western Cape	Somerset West
97	Union Hospital	Tjaart Venter	South Africa	Gauteng	Alberton
98	Vergelegen Medi-Clinic	Thomas Mabin	South Africa	Western Cape	Somerset West
99	Hospital Universitario Clinica Puerta de Hierro	Juan Manuel Escudier	Spain	Madrid	Majadahonda
100	Hospital Clínic i Provincial de Barcelona	Lluis Mont	Spain	Barcelona	Barcelona
101	Hospital Universitario Virgen de las Nieves	Luis Tercedor	Spain	Granada	Granada
102	Clínica Universitaria de Navarra	Naiara Calvo Galiano	Spain	Pamplona	Pamplona
103	Corporació Sanitària Parc Taulí	Eva Guillaumet Gasa	Spain	Barcelona	Sabadell
104	Hospital General Universitario Gregorio Mara？ón	Esteban González Torrecilla	Spain	Madrid	Madrid
105	Queen Elizabeth II Hospital	Diana Gorog	United Kingdom	Hertfordshire	Welwyn Garden City
106	Royal Bournemouth General Hospital	Richard Balasubramaniam (Bala)	United Kingdom	Dorset	Bournemouth
107	Queen Alexandra Hospital	Neil Andrews	United Kingdom	Portsmouth	Portsmouth
108	Chesterfield Royal Hospital	Justin Cooke	United Kingdom	Derbyshire	Chesterfield
109	Chesterfield Royal Hospital	Alastair Sandilands	United Kingdom	Leicestershire	Leicester
110	Nottingham City Hospital	Andrew Staniforth	United Kingdom	Nottinghamshire	Nottingham
111	Northampton General Hospital	Patrick Davey	United Kingdom	Cliftonville	Cliftonville
112	St George's Hospital	Irina Irina	United Kingdom	London	London
113	Mid-Ohio Heart Clinic, Inc.	James Bacon	United States	Ohio	Mansfield
114	Rapid City Regional Hospital	John Heilman	United States	South Dakota	Rapid City
115	BryanLGH Medical Center East	Steve Krueger	United States	Nebraska	Lincoln
116	Mobile Heart Specialists, PC	Noel Bedwell	United States	Alabama	Mobile
117	Fox Valley Clinical Research Center, LLC	Santosh Gill	United States	Illinois	Aurora
118	Tallahassee Research Institute	David Smith	United States	Florida	Tallahassee
119	Aultman Hospital	Ira Friedlander	United States	Ohio	Cantan
120	Buffalo Heart Group, LLP	Alan Meholick	United States	New York	Buffalo
121	Santa Rosa Cardiology Medical Group	John Hunter	United States	California	Santa Rosa
122	South Florida Research Solutions, LLC	Adam Splaver	United States	Florida	Hollywood
123	Johns Hopkins University	William Herzog	United States	Maryland	Columbia
124	Regional Cardiology Associates	Arash Aryana	United States	California	Sacramento
125	Center for Cardiovascular Research	Mark Chang	United States	Tennessee	Johnson City
126	Doylestown Hospital	Robert Sangrigoli	United States	Pennsylvania	Doylestown
127	Aspirus Cardiovascular Associates	German Larrain	United States	Wisconsin	Wausau
128	Precision Research Institute, LLC	Jerome Robinson	United States	California	National City
129	TriWest Research Associates	Suhail Zavaro	United States	California	El Cajon
130	Rush University Medical Center	Kousik Krishnan	United States	Illinois	Chicago
131	Silicon Valley Cardiology Medical Group	Rob Patrawala	United States	California	East Palo Alto
132	Cardiovascular Associates	Mohammmed Khan	United States	Illinois	Elk Grove Village
133	Rockford Cardiovascular Associates	Edward Telfer	United States	Illinois	Rockford
134	Columbia University Medical Center	Jose Dizon	United States	New York	New York
135	Scottsdale Healthcare Research Institute	Nassim Haddad	United States	Arizona	Scottsdale
136	Charles George VA Medical Center	Anil Goli	United States	North Carolina	Asheville
137	The Toledo Clinic, Inc.	Ahed Nahhas	United States	Ohio	Toledo
138	New Mexico Heart Institute	Ross Downey	United States	New Mexico	Albuquerque
139	VA Southern Nevada Healthcare System	Javed Tunio	United States	Nevada	North Las Vegas
140	Cardiology Associates of Fairfield County, PC	Mark Heiman	United States	Connecticut	Stamford
141	PeaceHealth St. Joseph Medical Center	John MacGregor	United States	Washington	Bellingham
142	Heritage Valley Heart and Vascular Center	Angel Flores	United States	Pennsylvania	Beaver
143	Office of Dr. Daniel Gottlieb, MD	Daniel Gottlieb	United States	Washington	Burien
144	BHS Cardiovascular Consultants	Sunder Rao	United States	Pennsylvania	Butler
145	Centennial Heart Cardiovascular Consultants	Robert Jones	United States	Tennessee	Nashville
146	Utah Cardiology, PC	Stephanie Olsen	United States	Utah	Layton
147	Vanderbilt University Medical Center	Pablo Saavedra	United States	Tennessee	Nashville
148	The Cleveland Clinic	Allan Klein	United States	Ohio	Cleveland
149	North Texas Heart Center, PA	Jorge Cheirif	United States	Texas	Dallas
150	Tyler Cardiovascular Consultants	Frank Navetta	United States	Texas	Tyler
151	Pinellas Arrhythmia Associates	John Norris	United States	Florida	Clearwater
152	Chinatown Cardiology, PC	Tak Kwan	United States	New York	New York
153	The Cardiovascular Center, PA	William David	United States	Florida	Deltona
154	Shady Grove Adventist Hospital	Sean Beinart	United States	Maryland	Rockville
155	Broward Health Medical Center	Arnoux Arnoux	United States	Florida	Ft. Lauderdale
156	Advanced Heartcare, LLC	Sharan Mahal	United States	New Jersey	Bridgewater
157	Florida Hospital Memorial Medical Center	David Henderson	United States	Florida	Daytona Beach
158	Brooke Army Medical Center	Ahmad Slim	United States	Texas	Fort Sam Houston
159	Alfieri Cardiology	Anthony Alfieri	United States	Delaware	Wilmington
160	Einstein Healthcare Network	Gregg Pressman	United States	Pennsylvania	Philadelphia
161	University of Chicago Hospitals	Hemal Nayak	United States	Illinois	Chicago
162	Penn State Milton S. Hershey Medical Center	Javier Banchs	United States	Pennsylvania	Hershey
163	Holy Cross Hospital	Rishi Anand	United States	Florida	Ft. Lauderdale
164	Anne Arundel Medical Center	Valeriani Bead	United States	Maryland	Annapolis
165	Drexel Cardiology	Steven Kutalek	United States	Pennsylvania	Philadelphia
166	Research One	Babak Vakili	United States	Florida	Orlando
167	Harbor - UCLA Medical Center	William French	United States	California	Torrance
168	Capital Cardiology Associates	Robert Morris	United States	New York	Troy
169	JPAZ Perfection Clinical, LLC	John Covalesky	United States	New Jersey	Manalapan
170	Texas Heart & Vascular	Vinh Nguyen	United States	Texas	Austin
171	Yale University School of Medicine	Mark Marieb	United States	Connecticut	New Haven
172	Health First Physicians, Inc.	Enrique Polanco	United States	Florida	Melbourne
173	East Coast Institute for Research	Ferris George, Jr.	United States	Florida	St. Augustine
174	East Coast Institute for Research	Albert Seals	United States	Florida	Jacksonville
175	Presence Saint Joseph Medical Center	Ahmad Abdul-Karim	United States	Illinois	Joliet
176	Jacksonville Center for Clinical Research	Michael Koren	United States	Florida	Jacksonville
177	Suncoast Research Group, LLC	Hector Jimenez	United States	Florida	Miami
178	Watson Clinic Center for Research	Kevin Browne	United States	Florida	Lakeland
179	Watson Clinic Center for Research	William Wallace	United States	Georgia	Savannah
180	UZ Leuven Gasthuisberg	Hein HEIDBUCHEL	Belgium	Vlaams Brabant	LEUVEN

序号	名称	审查结论	批准日期/备案日期
1	北京安贞医院	同意	2013-06-20

已完成

目标入组人数	国内: 80 ； 国际: 1500 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 65  ； 国际: 1504 ；

第一例受试者签署知情同意书日期	国内：2013.3.29；     国际：2012-10-03；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：2014-02-28；     国际：2014-01-24；