The HOPE (Heart Outcomes Prevention Evaluation) Study: the design of a large, simple randomized trial of an angiotensin-converting enzyme inhibitor (ramipril) and vitamin E in patients at high risk of cardiovascular events. The HOPE study investigators.

The HOPE (Heart Outcomes Prevention Evaluation) Study: the design of a large, simple randomized trial of an angiotensin-converting enzyme inhibitor (ramipril) and vitamin E in patients at high risk of cardiovascular events. The HOPE study investigators.
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HOPE(心脏结果预防评估)研究:针对心血管事件高危患者设计了一项针对血管紧张素转换酶抑制剂(雷米普利)和维生素 E 的大型、简单随机试验。

DOI:
10.1016/s0304-3975(03)00090-2
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发表时间:
1996
期刊:
The Canadian journal of cardiology
影响因子:
--
通讯作者:
R. Mack
R. Mack
中科院分区:
--
文献类型:
--
作者:
F. Mindlen;R. Nordaby;M. Ruiz;A. Zavala;L. Guzman;F. Martinez;R. Diaz;C. Mackey;M. Marino;G. Romero;G. Zapata;C. Cuneo;T. Kawamura;O. Coelho;O. Massayochi;J. Braga;A. Labrunie;L. Bodanese;E. Manenti;D. Vitola;J. Nicolau;C. Amodeo;D. Armaganijan;M. Bertolami;B. Caramelli;A. Carvalho;C. Cirenza;M. Fichino;R. Franken;N. Ghorayeb;T. Kadri;P. Leão;F. Malheiros;R. Pavanello;F. Ramires;J. Ramires;F. Savioli;A. Sousa;L. Tanajura;D. Topps;L. Korner;Martínez;B. Baptie;M. Basinger;B. Baylis;P. Beresford;A. Edwards;P. Giannaccaro;Y. Groenewoud;M. Grose;J. Kellen;S. Lam;R. Lesoway;P. Ma;D. Meldrum;D. Mitchell;L. Mitchell;D. Roth;S. Shumak;M. Simon;J. Stone;W. Warnica;D. Wyse;C. Neffgen;J. Neffgen;F. Armstrong;W. Armstrong;N. Bell;W. Black;N. Brass;F. Brenneis;R. Brownoff;G. Chaytors;D. Debanne;C. Derksen;M. Donoff;Dzavik;M. Goeres;P. Greenwood;S. Gulamhusein;W. Hui;K. Hutchison;L. Kasian;L. Kasza;E. Krikke;L. Kvill;Z. Lakhani;D. Linklater;J. Mackel;S. Martin;T. Montague;D. Moores;A. Musseau;T. Muzyka;J. Paradis;A. Prosser;E. Ryan;M. Senaratne;P. Stenerson;T. Talibi;K. Teo;C. Young;Zuk;Roseann M. White;K. Browne;M. Browne;K. Happel;A. Irving;A. Plesko;R. Donnelly;N. Radomsky;P. Felker;D. Larsen;J. Morse;C. Rowntree;J. Thompson;R. Wedel;G. Bloomberg;G. Chomin;M. Dahl;W. Leong;Moy;J. Heath;J. Marshall;M. Terwiel;G. Kenefick;R. Kuritzky;K. Stevens;K. Weddings;K. Barban;Imrie;K. Woo;T. Ashton;K. Calvert;W. Bishop;R. Sweeney;L. Breakwell;J. Kornder;S. Pearce;P. Polasek;P. Richardson;S. Ghosh;M. Rielly;K. Wagner;Bemstein;K. Dawson;P. Lee;J. Lewis;K. MacDonald;L. McGee;C. Thompson;D. Hilton;K. Illott;P. Klinke;J. Mcconnell;S. Rabkin;A. Ong;G. Ong;D. Bedard;R. Hoeschen;P. Mehta;Mohammad;A. Morris;R. Bessoudo;N. Dobbins;L. McLellan;Milton;R. Davis;D. OKeefe;Richard Smith;C. Joyce;M. Parsons;J. Skanes;B. Sussex;M. Tobini;M. Ravalia;G. Sherman;G. Worrall;A. Atkinson;R. Hatheway;B. Johnson;S. Barnhill;Bata;J. Cosseet;D. Johnstone;M. MacFarlane;W. Sheridan;L. Crossman;D. Folkins;M. Shirley;T. Machel;J. Morash;M. Gupta;M. Mayich;T. Vakani;T. Baitz;E. Macphee;E. Turton;M. Turton;N. Chan;J. Misterski;D. Raco;G. Curnew;E. Fallen;L. Finkelstein;H. Gerstein;P. Hardman;S. Lawand;E. Lonn;W. Magi;M. McQueen;A. Panju;R. Patterson;B. Sullivan;H. Sullivan;M. Sullivan;K. G. Taylor;Worron;S. Yusuf;W. Cameron;C. Noseworthy;R. Houlden;T. Lavalle;R. Fowlis;Janzen;M. Arnold;M. Cann;S. Carroll;S. Dumaresq;M. Edmonds;P. Furlong;C. Geddes;E. Graham;K. Harris;Hramiak;R. Kennedy;W. Kostuk;M. Krupa;B. Lent;M. Lovell;C. Maclean;D. Massel;R. Mcmanus;J. Mcsherry;C. Muñoz;J. Occhipinti;L. Oosterveld;P. Pflugfelder;S. Powers;R. Southern;D. Spence;P. Squires;S. Wetmore;J. Willing;G. Wisenberg;B. Wolfe;P. Kannampuzha;T. Rebane;Sluzar;A. R. Hess;Y. Chan;D. Thomson;R. Baigrie;J. Dubbin;C. Liuni;K. Tan;E. Brankston;P. Hewson;B. Hrycyshyn;W. Kapusta;L. Knox;C. Lockner;P. Whitsitt;M. Baird;D. Conroy;R. Davies;R. Davies;M. Fraser;S. Hagar;P. Hierlihy;E. Keely;S. Khan;D. Lau;L. Marois;K. Németh;E. Reeves;M. Turek;R. Vexler;D. Young;G. Kumar;G. Kuruvilla;P. Kuruvilla;D. Lowe;K. Kwok;J. Blakely;S. Styling;B. Bożek;J. Charles;D. Fell;D. Fell;E. Goode;LD Grossman;E. Matthews;R. Nitkin;J. Ricci;A. Selby;Nina P. Singh;J. Swan;J. Emmett;M. Weingert;F. Ganjavi;D. Hill;S. Nawaz;R. Hessian;K. Kwiatkowski;C. Lai;C. Mulaisho;H. OKeefe;H. Smith;A. Weeks;J. Andrews;A. Barnie;M. Drobac;P. Hacker;A. Hanna;M. Iwanochko;A. Kenshole;A. Langer;P. Liu;S. Maclean;G. Moe;Z. Sasson;L. Sternberg;C. Trachuk;J. Walters;B. Zinman;M. Cheung;C. Cinà;L. Yao;K. Man;J. Fulop;A. Glanz;M. Sibbick;P. Carter;J. Hickey;E. McMillian;D. Dion;R. StHilaire;D. Coutu;G. DAmours;R. Starra;J. Brooks;P. Dechamps;G. Kiwan;S. Kouz;M. LaForest;C. Rémillard;D. Bellamy;R. Brossoit;S. Carrier;A. Houde;Labonte;A. Bélanger;N. Kandalaft;L. Quenneville;M. Sandi;P. Auger;N. Bilodeau;F. Delage;F. Dumont;R. Giroux;R. Loisel;C. Poirier;D. Saulnier;P. Carmichael;C. Lemay;J. Lenis;N. Aris;H. Bedard;C. Casavant;J. Chiasson;D. Dagenais;D. Fitchett;D. Gossard;H. Halle;N. Hamel;M. Joyal;O. Magnan;M. Méthé;L. Pedneault;C. Pilon;D. Poisson;L. Primeau;C. Rondeau;C. Roy;M. Ruel;A. Serpa;F. Sestier;M. Smilovitch;P. Theroux;J. Beaudoin;Boudreault;D. D'amours;T. Douville;G. Giguère;G. Houde;R. Labbe;S. Lachance;L. Lessard;G. Mercier;HP Noel;P. Talbot;J. Tremblay;A. Karabatsos;K. Maclellan;P. Wilson;P. Bogaty;D. LaForge;M. Langlais;M. Leblanc;M. Samson;J. Turcotte;J. Campeau;R. Dupuis;C. Lauzon;F. Ouimet;G. Pruneau;C. Desmaris;Frechetto;P. Gervais;J. Brophy;S. Leroux;S. Bester;L. Meunier;M. Sayeed;M. Hart;Moumne;G. Thomasse;J. Walker;M. Walker;S. Ahmed;N. Habib;P. Kuny;J. López;W. Klein;M. Grisold;L. Heyndrickx;A. Fiasse;J. Degaute;J. Mockel;D. Duprez;J. Chaudron;A. Bodson;G. Krzentowski;J. Boland;K. Kølendorf;B. Winther;H. Juhl;T. Hamalainen;O. Siitonen;H. Gin;Rigalleau;J. Hensen;R. Riel;R. OehmenBritsch;B. Schulze;R. Hopf;A. M. Møller;C. Rosak;H. Wetzel;C. Hasslacher;T. Martin;J. Stein;E. Erdmann;M. Böhm;D. Hartmann;M. Breidert;R. Fritzen;W. Scherbaum;J. Mann;J. Maus;C. Schroeder;H. Henrichs;H. Unger;G. Ickenstein;E. Kromer;G. Riegger;H. Schunkert;B. Basan;R. Hampel;P. Crean;T. Garadah;U. White;N. Marini;E. Paciaroni;G. Saccomano;S. Diluzio;B. Magnani;B. Mantovani;P. Pareschi;N. Stucchi;D. Nanni;F. Rusticali;C. Simoni;C. Brunelli;S. Caponnetto;E. Gatto;A. Mazzantini;O. Molinari;R. Morello;L. Degiorgio;C. Imparato;F. Barbaresi;A. Cotogni;M. Pasqualini;G. Frigeni;M. Landoni;A. Polese;A. Cernigoi;M. Merni;C. Tortul;M. Velussi;F. Aina;C. Cernigliaro;P. Dellavesa;U. Dejoannon;G. Pierfranceschi;D. Zavaroni;R. Emilia;E. Manicardi;E. Minelli;F. Penazzoli;Portioli;E. Rossi;P. Giani;R. Roccaforte;M. Casaccia;R. Larovere;E. Miglierina;S. Repetto;P. Centofante;M. Vincenzi;A. Nieuwenhuijzen;J. Sels;B. Wolffenbuttel;J. Kip;L. Mantingh;H. Mulder;L. Vandoorn;E. Hjerkinn;Å. Reikvam;M. Cardona;G. Sanz;A. Karoni;LL Bescos;Albert;R. Masiá;Á. Álvarez;L. Sáenz;L. Astrom;R. Press;P. Sjostedt;F. Tabrizi;Bergbom;P. Hansson;C. Held;T. Kahan;B. Ryden;O. Andersson;M. Wysocki;E. Karlsson;G. Sartor;L. Smith;P. Katzman;L. Ljungdahl;P. Norén;A. Hallberg;P.‐O. Olsson;S. Åsbrink;J. Mølgaard;Nilsson;F. Nystrom;P. Ohman;C. Andersson;L. Ekholm;K. Svensson;E. Torebo;B. Fagher;Svenstam;T. Thulin;U. Ericsson;K. Ahnberg;R. Henning;L. Jacobsson;A. Taghavi;P. Ahlstrom;U. Rosenqvist;C. Ericson;O. Gertow;BE Kristensson;L. Stahl;L. Bergsten;R. Harden;C. Jagren;B. Leijd;P. Lennerhagen;J. Ostergrens;Sandstrom;R. Sundelin;A. Hagg;C. Morlin;F. Pettersson;A. Wanders;H. Bjorkman;G. Karlsson;H. Larsson;Y. Lonndahl;P. Weber;R. Cozzi;P. Gerber;T. Moccetti;E. Safwan;F. Sessa;T. Binder;P. Boman;W. Kiowski;R. Lehman;B. Lull;G. Spinas;A. Jamieson;J. Kennedy;C. Kesson;R. Gryczka;P. Parker;S. Sidiki;M. Small;S. Struthers;J. Manns;H. Smithurst;A. Begg;B. Fisher;C. Bedford;S. Heller;S. Marlow;Ernesto German Cordona Munoz;HH Garcia;Rogerio M. Ruiz;E. Meaney;Miranda Flores;E. Brown;G. Perry;G. Patel;R. J. Sarma;Y. Szlachcic;J. Dorman;B. N. Singh;G. Bailey;L. Clegg;L. Horwitz;J. Leahy;A. Rashkow;M. Hudson;A. Miller;J. Umberger;R. Zoble;P. Orander;M. R. Sridharan;G. DeFrancisco;M. Davidson;N. Islam;J. Mathew;R. Rajanahally;D. French;W. Wickemeyer;M. Effron;M. Goldstein;K. Utley;G. Pierpont;J. Weigenant;M. Farkouh;Kubly;M. Rich;L. Wisneski;J. Abrams;D. Garcia;M. Bonora;R. Kohn;E. Muffoletto;D. Brink;E. Lader;A. Singler;P. Pande;J. Powers;B. Hoogwerf;J. Moore;F. Yanak;S. Gupta;D. Williams;K. Danisa;C. Kirk;B. Wescott;J. Grover;M. Mackenzie;M. Amidi;M. Bell;J. Farmer;C. Kingry;J. Young;Harms;J. Kennedy;R. Letterer;C. Heller;R. Mack

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目的 描述HOPE(心脏结局预防评价)研究的设计。 设计 描述HOPE的关键设计特征,这是一项大型、简单的随机试验,研究了两种广泛适用的治疗方法--血管紧张素转换酶抑制剂雷米普利和天然抗氧化维生素E--预防心肌梗死、中风或心血管死亡。 设置 加拿大、美国、墨西哥、欧洲和南美洲的267家医院、医生办公室和诊所。 患者 在18个月内招募了9000多名年龄在55岁及以上的心血管事件(如心肌梗死和中风)高危人群。 干预措施 一项2X2析因设计,使用雷米普利和维生素E,随访长达4年。 结论 HOPE将是两种新干预措施的最大试验之一,以预防高危患者的心肌梗死,中风或心血管死亡。HOPE的结果将对公共卫生产生直接影响,并可能随时纳入临床实践。HOPE的关键设计特征是纳入心血管疾病高风险个体,纳入相当比例的糖尿病患者(36%)和女性(27%),以及详细的子研究,以提供有关获益机制的数据。
OBJECTIVE To describe the design of the HOPE (Heart Outcomes Prevention Evaluation) study. DESIGN Description of the key design features of HOPE, a large, simple randomized trial of two widely applicable treatments--ramipril, an angiotensin-converting enzyme inhibitor; and vitamin E, a naturally occurring antioxidant vitamin--in the prevention of myocardial infarction, stroke or cardiovascular death. SETTING Two-hundred and sixty-seven hospitals, physician offices and clinics in Canada, the United States, Mexico, Europe and South America. PATIENTS Over 9000 women and men aged 55 years and above at high risk for cardiovascular events such as myocardial infarction and stroke were recruited over 18 months. INTERVENTIONS A 2X2 factorial design with ramipril and vitamin E with follow-up for up to four years. CONCLUSIONS HOPE will be one of the largest trials of two new interventions to prevent myocardial infarction, stroke or cardiovascular death in high risk patients. The results of HOPE will have direct public health impact and are likely to be readily incorporated into clinical practice. Key design features of HOPE are inclusion of individuals at high risk of cardiovascular disease, inclusion of a substantial proportion of patients with diabetes (36%) and women (27%), and detailed substudies to provide data on mechanisms of benefit.