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出境医 / 临床实验 / 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
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
基本信息
| 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 | ||
公示的试验信息
一、题目和背景信息
| 登记号 | CTR20132867 | ||
|---|---|---|---|
| 相关登记号 | |||
| 药物名称 | 利伐沙班片 曾用名: | ||
| 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 | |
| 版本日期: | 方案是否为联合用药 | 企业选择不公示 | |
二、申请人信息
| 申请人名称 |
1
2
|
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|---|---|---|---|---|---|
| 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 | |
| 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 |
三、临床试验信息
1、试验目的
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。
2、试验设计
| 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 |
3、受试者信息
| 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 |
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| 排除标准 |
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4、试验分组
| 试验药 |
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|---|---|---|---|---|---|---|---|
| 对照药 |
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5、终点指标
| 主要终点指标及评价时间 |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 次要终点指标及评价时间 |
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6、数据安全监查委员会（DMC）
有
7、为受试者购买试验伤害保险
有
四、研究者信息
1、主要研究者信息
| 1 | 姓名 | Ricardo Cappato | 学位 | 职称 | 教授 | |
|---|---|---|---|---|---|---|
| 电话 | 390252774337 | riccardo.cappato@grupposandonato.it | 邮政地址 | Center of Clinical Arrythmia & Electrophysiology, I.R.C.C.S. Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy | ||
| 邮编 | 20097 | 单位名称 | Center of Clinical Arrythmia & Electrophysiology, I.R.C.C.S. Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy | |||
2、各参加机构信息
| 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 |
