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出境医 / 临床实验 / 在Vk拮抗剂治疗失败或不适用的房颤患者中预防卒中研究
在Vk拮抗剂治疗失败或不适用的房颤患者中预防卒中研究
基本信息
| 登记号 | CTR20132406 | 试验状态 | 进行中 |
|---|---|---|---|
| 申请人联系人 | 刘蔚 | 首次公示信息日期 | 2015-10-13 |
| 申请人名称 | 百时美施贵宝（中国）投资有限公司/ Bristol-Myers Squibb Company/ Bristol-Myers Squibb | ||
公示的试验信息
一、题目和背景信息
| 登记号 | CTR20132406 | ||
|---|---|---|---|
| 相关登记号 | |||
| 药物名称 | 阿哌沙班(BMS-562247)包膜片5 mg | ||
| 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 | 非瓣膜性房颤 | ||
| 试验专业题目 | 比较阿哌沙班与阿司匹林在维生素K拮抗剂治疗失败或不适用的房颤患者中预防卒中的作用 | ||
| 试验通俗题目 | 在Vk拮抗剂治疗失败或不适用的房颤患者中预防卒中研究 | ||
| 试验方案编号 | CV185-048 | 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
3
|
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|---|---|---|---|---|---|
| 联系人姓名 | 刘蔚 | 联系人座机 | 021-23218416 | 联系人手机号 | |
| 联系人Email | Kelly.liu@bms.com | 联系人邮政地址 | 上海市南京西路1717号会德丰广场59楼 | 联系人邮编 | 200040 |
三、临床试验信息
1、试验目的
对于患有房颤且至少还有一种卒中危险因素且不适合维生素K拮抗剂治疗或治疗失败的患者，明确阿哌沙班5mg BID（某些特定患者为2.5mg BID[每日二次]）在卒中或体循环栓塞复合事件的预防中是否优于ASA（81 - 324 mg QD[每日一次] ）
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 | 双盲 | 试验范围 | 国际多中心试验 |
3、受试者信息
| 年龄 | 50岁(最小年龄)至 NA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 | 朱俊 | 学位 | 职称 | 教授 | |
|---|---|---|---|---|---|---|
| 电话 | 010-88398866 | junzhuld@hotmail.com | 邮政地址 | 北京市西城区北礼士路167号中国医学科学院阜外心血管病医院 | ||
| 邮编 | 100037 | 单位名称 | 中国医学科学院阜外心血管病医院 | |||
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 | 中国医学科学院阜外心血管病医院 | 朱俊 | 中国 | 北京 | 北京 |
| 2 | 首都医科大学附属北京朝阳医院 | 杨新春 | 中国 | 北京 | 北京 |
| 3 | 上海交通大学医学院附属瑞金医院 | 陆国平 | 中国 | 上海 | 上海 |
| 4 | 上海长海医院 | 李莉 | 中国 | 上海 | 上海 |
| 5 | 哈尔滨医科大学第一医院 | 梁岩 | 中国 | 黑龙江 | 哈尔滨 |
| 6 | 武汉大学人民医院 | 蒋学俊 | 中国 | 湖北 | 武汉 |
| 7 | 中国医科大学第一附属医院 | 齐国先 | 中国 | 辽宁 | 沈阳 |
| 8 | 大连医大第一附院 | 高连君 | 中国 | 辽宁 | 大连 |
| 9 | 北京安贞医院 | 吴学思 | 中国 | 北京 | 北京 |
| 10 | 北京世纪坛医院 | 周北玲 | 中国 | 北京 | 北京 |
| 11 | 中国人民解放军第二炮兵总医院 | 胡桃红 | 中国 | 北京 | 北京 |
| 12 | 青岛市立医院 | 张放 | 中国 | 山东 | 青岛 |
| 13 | 广东省人民医院 | 吴书林 | 中国 | 广东 | 广州 |
| 14 | 中国人民解放军白求恩国际和平医院 | 李俊侠 | 中国 | 吉林 | 长春 |
| 15 | 中日友好医院 | 柯元南 | 中国 | 北京 | 北京 |
| 16 | 四川大学华西医院 | 陈晓平 | 中国 | 四川 | 成都 |
| 17 | 苏州大学附属第一医院 | 宋建平 | 中国 | 江苏 | 苏州 |
| 18 | 中国人民解放军总医院（301医院） | 杨庭树 | 中国 | 北京 | 北京 |
| 19 | Hospital Privado-Centro Medico De Cordoba S.A. | Amuchastegui, Luis Maria | Argentina | CORDOBA | Cordoba |
| 20 | Instituto Medico De La Comunidad (Imec) | Bustamante Labarta, Miguel Hugo | Argentina | BUENOS AIRES | Junin |
| 21 | Sanatorio Nuestra Senora Del Rosario | Bustamante, Gustavo | Argentina | JUJUY | San Salvador De Jujuy |
| 22 | Clinica Coronel Suarez | Caccavo, Alberto | Argentina | BUENOS AIRES | Coronel Suarez |
| 23 | Clinica Regional Del Este S.R.L. | Carmelo Paolasso, Horacio Cesar | Argentina | CORDOBA | San Francisco |
| 24 | Hospital Italiano De La Plata | Cartasegna, Luis Rodolfo | Argentina | BUENOS AIRES | La Plata |
| 25 | Clinica Privada Colombo | Colombo, Hugo Raul | Argentina | CORDOBA | Cordoba |
| 26 | Clinica Privada Del Prado | Covelli, Guillermo | Argentina | CORDOBA | Cordoba |
| 27 | Framingham Centro Medico | Cuadrado, Jesus Abel | Argentina | BUENOS AIRES | La Plata |
| 28 | Hospital Gen. De Agudos Jose Maria Ramos Mejia | Elizari, Marcelo Victor | Argentina | BUENOS AIRES | Buenos Aires |
| 29 | Clinica Privada Provincial S.A. | Garrido, Marcelo Alejandro | Argentina | BUENOS AIRES | Merlo |
| 30 | Instituto De Investigaciones Clinicas Quilmes | Hrabar, Adrian Demetrio | Argentina | BUENOS AIRES | Quilmes |
| 31 | Instituto De Investigaciones Clinicas De Mar Del Plata | Mackinnon, Ignacio Jorge | Argentina | BUENOS AIRES | Mar Del Plata |
| 32 | Centro Medico Consultan Salud | Marino, Javier Claudio | Argentina | BUENOS AIRES | Haedo |
| 33 | Dim Clinica Privada | Montana, Oscar Romano | Argentina | BUENOS AIRES | Ramos Mejia |
| 34 | Clinica Instituto Medico Adrogue | Schygiel, Pablo Omar | Argentina | BUENOS AIRES | Adrogue |
| 35 | Instituto De Investigaciones Clinicas Zarate | Vico, Marisa Liliana | Argentina | BUENOS AIRES | Zarate |
| 36 | Instituto De Investigaciones Clinicas Bahia Blanca | Vogel, Daniel Raul | Argentina | BUENOS AIRES | Bahia Blanca |
| 37 | Ciprec S.A. | Zaidman, Cesar Javier | Argentina | BUENOS AIRES | Autonoma |
| 38 | Clinica Chutro S.R.L. | Jure, Horacio Omar | Argentina | CORDOBA | Cordoba |
| 39 | Instituto Del Corazon | Kuschnir, Emilio | Argentina | CORDOBA | Cordoba |
| 40 | Clinica Privada Caraffa | Ramos, Hugo Roberto | Argentina | CORDOBA | Cordoba |
| 41 | Instituto De Cardiologia De Corrientes Juana Francisca Cabra | Pozzer, Domingo Luis | Argentina | CORRIENTES | Corrientes |
| 42 | Hospital San Bernardo | Cuneo, Carlos Alberto | Argentina | SALTA | Salta |
| 43 | Centro De Investigaciones Clinicas Del Litoral S.R.L. | Hominal, Miguel Angel | Argentina | SANTA FE | Santa Fe |
| 44 | Instituto De Investigaciones Clinicas De Rosario | Llanos, Javier | Argentina | SANTA FE | Rosario |
| 45 | Sanatorio Britanico De Rosario S.A. | Piskorz, Daniel Leonardo | Argentina | SANTA FE | Santa Fe |
| 46 | Hospital Italiano | Ramos, Jose Luis | Argentina | SANTA FE | Rosario |
| 47 | Investigaciones Clinicas Tucuman | Hasbani, Eduardo Gabriel | Argentina | TUCUMAN | San Miguel De Tucuman |
| 48 | Instituto De Cardiologia S.R.L. | Risso Patron, Facundo | Argentina | TUCUMAN | San Miguel De Tucuman |
| 49 | Concord Repatriation General Hospital | Brieger, David Bernard | Australia | New South Wales | Concord |
| 50 | Nepean Hospital | Coulshed, David | Australia | New South Wales | Penrith |
| 51 | Liverpool Hospital | French, John K | Australia | New South Wales | Sydney |
| 52 | Renal Research | Roger, Simon | Australia | New South Wales | Gosford |
| 53 | Northern Sydney Central Coast Area Health Service | Rogers, James | Australia | New South Wales | Gosford |
| 54 | St. George Private Hospital | Sader, Mark | Australia | New South Wales | Kogarah |
| 55 | Coffs Harbour Health Campus | Waites, Jonathon | Australia | New South Wales | Coffs Harbour |
| 56 | Core Research Group | Colquhoun, David | Australia | Queensland | Milton |
| 57 | Wesley Research Institute | Cross, David | Australia | Queensland | Auchenflower |
| 58 | Princess Alexandra Hospital | Garrahy, Paul | Australia | Queensland | Woolloongabba |
| 59 | Gold Coast Hospital | Jayasinghe, Rohan | Australia | Queensland | Southport |
| 60 | Peninsula Clin Rsrch Ctr | Karrasch, Jeffrey | Australia | Queensland | Kippa Ring |
| 61 | Peninsula Clinical Research Center | Karrasch, Jeffrey | Australia | Queensland | Kippa Ring |
| 62 | Geelong Hospital | Amerena, John | Australia | Victoria | Geelong |
| 63 | Joondalup Cardiovascular Trials Foundation Inc. | Purnell, Peter | Australia | Western Australia | Joondalup |
| 64 | Medizinische Universitat Graz | Fazekas, Franz | Austria | Graz | Graz |
| 65 | L K H-Univ. Klinikum Graz | Pieske, Burkert | Austria | Graz | Graz |
| 66 | Landes-Nervenklinik Wagner-Jauregg | Aichner, Franz | Austria | Linz | Linz |
| 67 | Krankenhaus Der Barmherzigen Brüder Linz | Eggers, Christian Claas | Austria | Linz | Linz |
| 68 | Allgemeines Krankenhaus Linz | Gruber, Franz | Austria | Linz | Linz |
| 69 | St. Johanns Spital-Salzburger Landeskliniken | Danmayr, Franz | Austria | Salzburg | Salzburg |
| 70 | A.O. Krankenhaus Oberpullendorf | Stockenhuber, Felix | Austria | Oberpullendorf | Oberpullendorf |
| 71 | Onze-Lieve-Vrouwziekenhuis | Jozef Goethals, Marc Antoon Maria | Belgium | Aalst | Aalst |
| 72 | Az Klina | Cools, Frank | Belgium | Brasschaat | Brasschaat |
| 73 | Universitair Ziekenhuis Brussel | Schoors, Danny | Belgium | Brussels | Brussels |
| 74 | Az Sint-Jan | Vandekerckhove, Yves | Belgium | Brugge | Brugge |
| 75 | Hopital Erasme | Jottrand, Maurice | Belgium | Bruxelles | Bruxelles |
| 76 | Cardio Vascular Detection Centre | Hollanders, Geert | Belgium | De Pinte | De Pinte |
| 77 | Heilig Hart Ziekenhuis Roeselare | Anne, Wim | Belgium | Roeselare | Roeselare |
| 78 | Az Turnhout Campus Sint-Elizabeth | J.F. Thoeng, John Khe Goan | Belgium | Turnhout | Turnhout |
| 79 | Chr De Huy | Marechal, Patrick | Belgium | Huy | Huy |
| 80 | Hartcentrum | Van Mieghem, Walter | Belgium | Genk | Genk |
| 81 | Fundacao Bahiana De Cardiologia | Rabelo Junior, Alvaro | Brazil | Bahia | Salvador |
| 82 | Real Sociedade Portguesa Beneficencia 16/Set - Hosp Prt | Teixeira, Marcelo | Brazil | Bahia | Salvador |
| 83 | Sociedade Educacional Uberabense | Avezum Oliveira, Livia Figueira | Brazil | Minas Gerais | Uberaba |
| 84 | Hospital Mater Dei Sa | Lichter, Artur Peretz | Brazil | Minas Gerais | Belo Horizonte |
| 85 | Santa Casa De Misericordia De Belo Horizonte | Reis, Gilmar | Brazil | Minas Gerais | Belo Horizonte |
| 86 | Universidade Federal Do Triangulo Mineiro | Salgado De Melo, Celso | Brazil | Minas Gerais | Uberaba |
| 87 | Associacao Beneficiente Bom Samaritano | D'Aurea Mora Jr., Raul | Brazil | Parana | Maringa |
| 88 | Nucleo De Pesquisa Clinica S/S | Ferreira Rossi, Paulo Roberto | Brazil | Parana | Curitiba |
| 89 | Irmandade Da Santa Casa De Misericordia De Curitiba | Moura Jorge, Jose Carlos | Brazil | Parana | Curitiba |
| 90 | Hospital De Clinicas Da Universidade Federal Do Parana | Pereira Da Cunha, Claudio Leinig | Brazil | Parana | Curitiba |
| 91 | Sociedade Hospitalar Angelina Caron | Precoma, Dalton Bertolim | Brazil | Parana | Campina Grande De Sul |
| 92 | Fundacao Publica Estadual Hosp. De Clin. Gaspar Vianna Fhcgv | Reis, Helder Jose Lima | Brazil | Para | Belem |
| 93 | Hospital Universitario Pedro Ernesto - Uerj | Albuquerque, Denilson Campos De | Brazil | Rio De Janeiro | Rio De Janeiro |
| 94 | Natal Hospital Center Sa | Paiva, Maria-Sanali | Brazil | Rio Grande Do Norte | Natal |
| 95 | Hospital Sao Lucas Da Pucrs | Abunader Kalil, Carlos Antonio | Brazil | Rio Grande do Sul | Porto Alegre |
| 96 | Fundacao Universitaria De Cardiologia | Dutra, Oscar Pereira | Brazil | Rio Grande do Sul | Porto Alegre |
| 97 | Fundacao Universitaria De Cardiologia | Glotz De Lima, Gustavo | Brazil | Rio Grande do Sul | Porto Alegre |
| 98 | Irmandade Da Santa Casa De Misericordia De Porto Alegre | Leaes, Paulo Ernesto | Brazil | Rio Grande do Sul | Porto Alegre |
| 99 | Associacao Educadora Sao Carlos Hospital Mae De Deus | Manenti, Euler R. Fernandes | Brazil | Rio Grande do Sul | Porto Alegre |
| 100 | Hospital Nossa Senhora Da Conceicao Sa | Pimentel Filho, Pedro | Brazil | Rio Grande do Sul | Porto Alegre |
| 101 | Hospital De Clinicas De Porto Alegre | Polanczyk, Carisi Anne | Brazil | Rio Grande do Sul | Porto Alegre |
| 102 | Secretaria De Estado De Saude Instituto De Cardiologia Ic | De Azeredo Coutinho, Mario Sergio Soares | Brazil | Santa Catarina | Sao Jose |
| 103 | Sociedade Divina Providencia Hospital Santa Isabel | Zimmermann, Sergio Luiz | Brazil | Santa Catarina | Blumenau |
| 104 | Hospital Estadual Mario Covas De Santo Andre | Aziz, Jose Luis | Brazil | Sao Paulo | Santo Andre |
| 105 | Braile Clinica De Servicos E Assistencia Medica Hospitalar | Braga Braile, Maria C.Valarie | Brazil | Sao Paulo | Sao Jose Do Rio Preto |
| 106 | Spdm / Hospital Sao Paolo | Carmargo Carvalho, Antonio Carlos De | Brazil | Sao Paulo | Sao Paulo |
| 107 | Instituto Dante Pazzanese De Cardiologia | De Figueredo, Oliveira B | Brazil | Sao Paulo | Sao Paulo |
| 108 | Unicardio Rio Preto Ltda. | Francischetti, Aloisio | Brazil | Sao Paulo | Sao Jose Do Rio Preto |
| 109 | Irmandade Da Santa Casa De Misericordia De Sao Paulo | Franken, Roberto Alexandre | Brazil | Sao Paulo | Sao Paulo |
| 110 | Prevencor, Centro De Prevencao E Tratamento Cardiovascular | Garbelini Junior, Benito | Brazil | Sao Paulo | Marilia |
| 111 | Instituto Do Coracao De Marilia | Guimaraes Filho, Fabio Villaca | Brazil | Sao Paulo | Marilia |
| 112 | Instituto Dante Pazzanese De Cardiologia | Indio Do Brasil, Clarisse Kaoru Ogawa | Brazil | Sao Paulo | Sao Paulo |
| 113 | Sociedade Campineira De Educacao E Instrucao | Kerr Saraiva, Jose Francisco | Brazil | Sao Paulo | Campinas |
| 114 | Instituto Dante Pazzanese De Cardiologia | Liporace, Idelzuita | Brazil | Sao Paulo | Sao Paulo |
| 115 | Equipamentos Cardiovasculares Rio Preto Ltda | Lorga Filho, Adalberto Menezes | Brazil | Sao Paulo | San Jose- Do Rio Preto |
| 116 | Faculdade Regional De Medicina Sao Jose Do Rio Preto | Maia, Lilia | Brazil | Sao Paulo | San Jose- Do Rio Preto |
| 117 | Instituto Dante Pazzanese De Cardiologia | Moreira, Dalmo Antonio R | Brazil | Sao Paulo | Sao Paulo |
| 118 | Faculdade De Medicina De Marilia | Pelloso, Eraldo Antonio | Brazil | Sao Paulo | Marilia |
| 119 | Incor-Hospital Das Clinicas Fmusp | Pereira Barretto, Antonio Carlos | Brazil | Sao Paulo | Sao Paulo |
| 120 | Universidade Estadual Paulista Julio De Mesquita Filho | Politi Okoshi, Marina | Brazil | Sao Paulo | Botucatu |
| 121 | Instituto De Ortopedia E Traumatologia (Iot) Do Hcfmusp | Sguizzatto, Guilherme Turolla | Brazil | Sao Paulo | Sao Paulo |
| 122 | Spdm / Hospital Sao Paolo | Vincenzo De Paola, Angelo Amato | Brazil | Sao Paulo | Sao Paulo |
| 123 | Dr. Patrick T S Ma | Ma, Patrick | Canada | Ab | Calgary |
| 124 | Dr. Akbarally V. Lalani | Lalani, Akbarally V | Canada | Bc | New Westminster |
| 125 | Rivergrove Medical Clinic | Saunders, Kevin K | Canada | Mb | Winnipeg |
| 126 | Randy Hart, Md | Hart, Randy | Canada | Nl | St. John's |
| 127 | Dr. Asaad Bakbak | Bakbak, Asaad I | Canada | On | Oshawa |
| 128 | Jbn Medical Diagnostic Services Inc | Berlingieri, Joseph C | Canada | On | Burlington |
| 129 | Heart Care Research | Bhargava, Rakesh | Canada | On | Oshawa, Ontario |
| 130 | St. Michael'S Hospital | Dorian, Paul | Canada | On | Toronto |
| 131 | Hamilton Health Sciences-Hamilton General Hospital Site | Eikelboom, John William Andrew | Canada | On | Hamilton |
| 132 | Dr. Martin Stephen Green | Green, Martin Stephen | Canada | On | Ottawa |
| 133 | Hamilton Health Sciences | Healey, Jeffrey Sean | Canada | On | Hamilton |
| 134 | Dr. Laurie Leigh Hill | Hill, Laurie Leigh | Canada | On | Brampton |
| 135 | Dr. Campbell Duncan Joyner | Joyner, Campbell Duncan | Canada | On | Toronto |
| 136 | Andy S.C. Lam West Lincoln Memorial Hospital | Lam, Andy | Canada | On | Grimsby |
| 137 | Shah Nawaz, Md | Nawaz, Shah | Canada | On | Sudbury |
| 138 | Michael F.J. O'Mahony London Road Dia Clin & Med Centre | O'Mahony, Michael F.J | Canada | On | Sarnia |
| 139 | Cambridge Cardiac Care Centre | Pandey, A. Shekhar | Canada | On | Cambridge |
| 140 | G.S. Cardiac Lab | Syan, Gurcharan Singh |
