A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee.
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Serval ID
serval:BIB_9BB868942EFA
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee.
Journal
Lancet
Working group(s)
CAPRIE Steering Committee
Contributor(s)
Beaumont D., Blanchard J., Bousser M.G., Coffman J., Easton J.D., Hampton J.R., Harker L.A., Janzon L., Kusmierek J.J., Panak E., Roberts R.S., Shannon J.S., Sicurella J., Tognoni G., Tool E.J., Verstraete M., Warlow C., Verstraete M., Easton J.D., Bousser M.G., Cairns J.A., Chesebro J.H., Hampton J.R., von der Lippe G., Ross Russell R.W., Wolf P.A., Boissel J.P., Friedman L., Fuster V., Harrison M.G., Pocock S., Weksler B.B., Gent M., Foster G., Lewis G., Lychak T., Nelson H.L., Roberts R.S., Sicurella J., Sicurella J., Stewart C., Szechtman B., Chrolavicius S., Copland I., Jedrzojawski B., McCreadie F., Wilkinson L., Vonderveehn S., Boissel J.P., Boutitie F., Beaumont D., Perdriset G., Thizon de Gualle I., Hoek J., Besnier M.O., Boddy A., Brooker D., Derzko G., Jones A., Metzinger C., Novack J., Pratt S., Roome D., Schulhof J.P., Vallee E., Valtier D., Bastida E., Coy L., Creek R., Destelle G., Döberl T., de la Forest-Divonne N., Gallo G., Garcia A., Geudelin B., Hundt F., Hylkema R., Vanhove P., Amalfitano N., Cabala K., Caniglia J., Duval I., Forgie L., Neiss A.C., Wesseling T., Plehn J.F., Kennedy S.J., Zwolak R.M., Reeves A., McDaniel M.D., MacDonald G.J., Murphy C., Howes P.S., Cornell L.K., Hynes M.L., Jackson C.M., Lyden P.D., Rothrock J.F., Hye R.J., Dittrich H.C., Kelly N.M., Kerridge C.M., Chippendale T., Lobatz M., Diamond E., Schim J., Sadoff M., Logan W., Auer A., Hamilton W., Frere R., Schroer S., Wilcox M., Naeger C., Harbison J.W., Makhoul R., Taylor J.R., Felton W.L., Lee H.M., Massey-Makhoul K., Browne K.F., Tyson G.S., Pineiro E., Brenner A.S., Ford R.A., Reddy P.J., Owens P., Heinsimer J., Richter K., Markowski K., Lentini T., Howell L., Colfer H.T., Rynbrandt D.J., Wendt C.D., Wilmot M., Stone B., Touchon R., Briley D., Adkins L., Roe K., Harless C., DeWood M.A., Skidmore J.A., Randall J.M., Davenport J., Farmer C., Hanson S., Kuo L.C., Brown P., DesJardins J., Halpern N., Talbot W., Schainfeld R., Rosenfield K., Isber J.M., Grall E., Lanza S., Walker P.A., Ivanhoe R.J., Milunski M.R., Kereiakes D.J., Abbottsmith C.W., Lausten D.A., Helgason C.M., Glover V., Gnutek T., Clark W.M., Coull B.M., Harrison E., Suh J.T., McBride J.W., Foster B., Vittum K., Lauer N.Y., Adornato B.T., Adornato M.K., Fisher M., Ameriso S.F., Scicli A., Starling M.R., Petrusha J.A., Devlin W.H., Suter C.C., Tucci J., Stewart S.H., Sadowsky C., Stone R., Tuchman M., Massin E.K., Anderson H.V., Harlan M., Abrams J., Timm C., Rosenberg G., Hiatt W.R., Regensteiner J.G., Bauer T., Frey J.L., Darbonne C., Marlor L., Haire W.D., Stephens L.C., Kotulak G.D., Iteld B., VanderStappen A., Neuman V., Kleiman N., Bushman L., Fischer A., Clark W.M., Harrison E., Moon H., Klassen A.C., Berman M.E., Sufit R., Biller J., Olin J.W., Pirzada C.A., Medical V.A., Hershey L.A., Burch K., Castaldo J., Jenny D., Wohlberg C., Gaines K., Cape C., Gupta S.K., Landa R.A., Norcross S.R., Culebras A., Pastor D.C., Fairman R.M., Zakulec S., Sutton J.M., McCullough T., Fenster P.E., Feinberg W.M., Pellegrino R.G., Jeffers C., Smith W.B., Vargas R., McCormick T., Ramadan N.M., Levine S.R., Hirsch A.T., Wasserman A.G., Nys A., Breslin D.J., Labib S.B., Woodhead G., Matzura T.M., Dunlap S., Goodman M.A., Cappelli J., Stein P., Nadamanee K., Havranek E., Weinberger J., Lava N.S., Horowitz S., Byer J., Wentworth D., Dexter J.D., Bonnett A., Vetrovec G.W., O'Brien R.P., Easton J.D., Wilterdink J.L., Gelber D.A., Hemberger S., Sherman D., Rogers D., Alberts M.J., McClenny C., Weeks K.D., Whisnant D., D'Alton J., Doolittle H., Siller K.A., Hass W.K., Grines C., Timmis G., Gorelick P.B., Robinson D., Lumsden A.B., MacDonald J., Hughes R.L., Noonan V., Goldberg G., Costello R., Mohiuddin S., Stengel L., Frankel M.R., Braimah J., Creager M.A., Baum P., Cooke J.P., Ma A., Babikian V.L., O'Neal M.A., Mirsen T., Bruegel C., Coffman J.D., Brindley D.C., Mick M., Korenman S.G., Brass L.M., Asher S.W., Halperin J.L., Schlesinger R., Gacioch G.M., Couch J.R., Skolnick B.E., Ware M.S., Anderson J., Knepper L., Victor M., Ball S., Gurley J.C., Jessup M., Elkayam U., Hughes W.G., Fraser J.A., Potvin E.A., McMillan J., Grierson J., Hartwick N., Musclow S., Thompson A., Mewett J., Sivan R., Turpie A.G., Morino S., Siguenza M., Blakely J.A., Styling S., Balleza L., Beanlands D.S., Garrard L., Morgan K., Ruddy T., Morris A.L., Anderson B.A., Arneja A.S., Carter S.A., Daniels V., McEwen B., Ricci A.J., Swan J.H., Goode J.E., Selby D.A., Bozek B., Shuaib A., Yeung M., Press M., Walston L.L., Fung A.Y., Henning H., Taylor D.C., Abbey H., Davies C., Saunders L., Tanser P.H., Feldman D., Sullivan B., Sayles M.J., Kent E., Connolly S.J., Coletta E., Carruthers V., Hui W., Klinke P., Brass N., Kvill L., Cusson J., Van Nguyen P., Marchand L., Roy S., Blair J.F., Wellington J.L., Rody K., Poloni S., Myers M.G., Morgan C.D., Parsons P., Lecours R., Patanaude J.V., Turcotte C., Gutelius J.R., Pattenden R., Gagnon R.M., Racine N., Roy C., Harris K., Lovell M., Teal P.A., Bloomer J.L., Thompson C.R., Wong M., Sladen J.G., MacDonald K., Heinrich D., Houde G., Nadeau C., Talbot P., Pagé A., Verdant A., Smilovitch M., Racine N., Steinmetz O., Simard D., Benguigui C., Ouellet C., LeBrun L.H., Desrochers M.P., Finnie K., McCreery S., Kostuk W.J., Pflugfelder P.W., Oskalns R., Bonet J.F., Ilott K., McConnell J., Ruel M., Primeau L., Phillips S., Coleman-Kamphuis L., Leclerc J.R., Solymoss S., Côté R., Bourque F., Lee T.K., Kvill L., Bernstein V., Doyle L., Timothee J.R., Chebayeb R., Lefkowitz C., Hambly P., Klein G.M., Robertson M., Bayer N., Couse P., Norris J.W., Medel M.J., Sevitt B., Fitzsimons J., Fitchett D., Serpa A., Marr D., Ouellet B., Bellavance A., Pryse-Phillips W., Howse D.C., Rabkin S.W., McCans J., Brandjes D.P., Büller H.R., Dÿkema A.R., Kromhout J.G., Lawson J.A., Peters R.J., van der Sande J.J., Stam J., Blok L.M., Jenner Y., Ternede O., Lens J., Bollen E.C., Welten R.J., Termeulen P., Hollanders W.P., Lok D.J., Groeneveld H., Bouwens L.H., Tietge F.C., van der Velden E.C., Bruggink-André P.W., van Iersel G.J., Seegers J., van Vliet A.C., van der Sar P., Verhoog B.D., van der Sar de Nooijer S.H., Verhoog-Nijhuis I., Franke C.L., Koehler P.J., van der Meer J., van Os J.S., van der Heijden M., van Wijk L.M., Kragten J.A., de Warrimont-Henquet J., Feld R., Van Gemert H.M., Dippel D.W., Koudstaal P.J., Vanneste J.A., Linssen W.H., Kruisdijk J.J., Visser J., Van Gool T.F., Vooges J., De Vries A.C., Klinkert P., Bartlema K.A., Banga J.D., Niemeijer-Kanters S.D., de Groot M.G., Moll F.L., Sybrandy R., Buth J., Schol F.P., Donders R.C., Algra A., Pop G.A., van der Heijden R., Knippenberg B., Sier J.C., Berqvist D., Karacagil S., Eriksson I., Bowald S., Holmberg A., Ljungman C., Westman B., Sivenius J., Puranen J., Karinen A., Onatsu J., Salmenperä T., Kalinen M., Kaste M., Tatlisumak T., Soinne L., Kallela M., Kotila M., Hartford M., Herlitz J., Karlson B.W., Strömblad S.O., Olofsson B.O., Strand T., Kristensen B., Malm J., Melin J.H., Virtanen M., Olli T., Lindgärde F., Pessah-Rasmussen H., Rendell M., Ericsson U.B., Sahlman A., Savolainen H., Rämö J., Lehtonen J., Hillbom M.E., Reunanen M., Turkka J., Ylönen K., Peltola T., Juvonen T., Koskela E., Erkinheimo J., Ängquist K.A., Hedberg B., Arnerlov C., Rissanon A., Murros K., Idänpään-Heikkilä U., Honka L., Heikkilä J., Tiensuu T., Boberg J., Berggren A.L., Thompson P.L., Yu E.T., Bradshaw P.J., Cooke P.A., Gordon S.P., Loh K.S., McQuillan B., Moshiri M.M., Cross D.B., Egerton W.S., Walker P.J., Codd C.A., Kreuter D.A., Cox S., Naik D., Cavaye D.M., Harel M.C., Horowitz J., Rowe C., Stewart S., Boundy K., Stringer C.F., Anderson J.L., Coller D., Aylward P., Anderson C., Burns R., Schultz D., Waddy P., Walsh J., Davies L., Harris J.P., Wetzlar A., McDougall A., Sieunarine K., Cremer P., Donnan G.A., Tonkin A., Levi C., Hanlan J., Ellery F., White H.D., Hamer A.W., Kapadia V., Ramanathan K., Taylor R.R., Hankey G., Brooks M., Young T., McInerney M., Sansom J., Thomson R., Spaulding C., Cutforth R., Thomson A., Salem H.H., Coughlin P., Campbell T.J., Lord R.S., O'Sullivan D., Corrigan C., D'Arcy S., Anderson N.E., Charleston A.J., Davis S.M., Gerraty R., Bett N., Hewson D.J., Kester R.C., Scott D.J., Berridge D.C., Kent P.J., Thornton C.A., Sykes H., Bennett S., Blakey D., Brooksby W.P., Johnston R.T., Brack M., Hampton J.R., Vowden P., Gough M.J., Hooper R., Gough M., Hanley S.P., MacAskill M., Miles J., Waywell C., Mucklow J.C., Davis C., Harper P., Cooke K., Lowe G., Shaw B., McKillop J., Dormandy J.A., Chaudhry H., Evans J., Bamford J.M., Blundell S., Venables G., Doyle C., Shearman C.P., Crow A., Dennis M., Sandercock P., Brown M.M., Rogers J., Boyle R.M., Wiseman B.S., Humphrey P.R., Prentice C.R., Moccetti T., Pasotti E., Sessa F., Bertolini A., Rossi A., Del A., Malacrida R., Moccetti D., Besomi G., Mattle H.P., Eicher Vella E., Maurer D., Rihs F., Hoffmann U., Bollinger A., Franzeck U.K., Mahler F., Do D., Baumgartner I., Weder B., Bönig L., Ludin H.P., Bogousslavsky J., Maeder-Ingvar M., Regli F., Kappenberger L., Depairon M., Bizzini G., Beretta-Piccoli C., Elshater-Zanetti F., Guffi C., Bertel O., Deseö T., Gmuer W., Bounameaux H., Wicky J., Desmarais S., Vogt P., Fellay D., Rhyner K., Wojtyna W., Bonetti T., Brunner J., Jäger K.A., von Planta I., Noseda G., Pugliesi A., Pons-Giudici L., Meier B., Evéquoz D., Schmidt D., Keel H.S., Heinrich D., Follath F., Brunner H.P., Caduff B., Wirth M., Vuilliomenet A., Savcic M., Hürlimann U., Bosshard E., Hacke W., Brandt T., Wildermuth S., Ringleb P., Busse O., Straeten V., Zeuner K., Vielhaber S., Tettenborn B., Krämer G., Allardt A., Schmitt-Henco E., Diener H.C., Schrader V., Nebe J., Pilger E., Doder A., Gürtl B., Diehm C., Gomer M., Jansen T., Kömpf D., Kaps M., Vidal-Langwasser M., Hennerici M., Daffertshofer M., Schminke U., Osterhues H.H., Fischer A., Rupprecht H.J., Borkowski U., Rudofsky G., Rescher A., Schwerdt H., Hammer B., Voss R., Grebe M., Rieger H., Grobe R., Theiss W., Schaub F., Neumann F.J., Lutilsky L., Aichner F.T., Schmidauer C., Erdlenbruch K., Mórsdorf B.S., Hornig C.R., Moulin T., Chavot D., Autret A., Lucas C., Leys D., Henon H., Chedru F., Ameri A., Dunand J.F., Dambrine P., Gabriel A., Labaki F., Tran-Tranh X., Jouannon C., Durup F., Pagès M., Blard J.M., Giroud M., Menassa M., Zuber M., Mas J.L., Hommel M., Besson G., Laurian C., Mathieu J.F., Geraud G., Larrue V., Ben-Hamda K., Fumey R., Guiraud-Chaumeil B., Chollet F., Pathé M., Zannier-Marzari D., Chabriat H., Amarenco P., Pinel J.F., Beaune J., Pichard J.B., Medvedowsky A., Becker F., Terriat B., Woimant F., Cathelineau G., Martin Jadraque I., López Sendon J.L., Gonzales Maqueda I., Roldan Rabadan I., Cruz Fernández J.M., López Garcia V., Ros Die E., Gonzáles Rios J., Del Foco O., Chamorro A., Alday M., Matias-Guiu J., Gracia F., Pomar Moya-Prats J.L., Mestres C.A., Jiménez Cossio J.A., Riera de Cubas L., Barreiro Tella P., Diez Tejedor E., Cunha L., Goncalves A.F., Ferro M.A., Barbosa V., Santiago D., Ferro J.M., Melo T.P., Oliveira V., Pinto A.N., Bordalo-Sá A.L., Ferreira D., Tuna J.L., Providência L., Morais J., Pimenta A., Van de Werf F., Luyten A., Luys C., Blecic S.A., Van Blercom N.G., Hildebrand J.G., Sadzot B., Franck G., Brohet C., Huyberechts D., Zicot M., Petermans J., Duprez D.A., Clement D.L., Verhaeghe R., Peerlinck K., De Reuck J., Bosschaerts T., Wautrecht J.C., Coccheri S., Fortunato G., Catalano M., Libretti A., Carolei A., Mearelli S., Gresele P., Selli L., Nenci G.G., Morini M., Cortellaro M., Chierchia S.L., Luca Messa G.
ISSN
0140-6736 (Print)
ISSN-L
0140-6736
Publication state
Published
Issued date
16/11/1996
Peer-reviewed
Oui
Volume
348
Number
9038
Pages
1329-1339
Language
english
Notes
Publication types: Clinical Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
Many clinical trials have evaluated the benefit of long-term use of antiplatelet drugs in reducing the risk of clinical thrombotic events. Aspirin and ticlopidine have been shown to be effective, but both have potentially serious adverse effects. Clopidogrel, a new thienopyridine derivative similar to ticlopidine, is an inhibitor of platelet aggregation induced by adenosine diphosphate.
CAPRIE was a randomised, blinded, international trial designed to assess the relative efficacy of clopidogrel (75 mg once daily) and aspirin (325 mg once daily) in reducing the risk of a composite outcome cluster of ischaemic stroke, myocardial infarction, or vascular death; their relative safety was also assessed. The population studied comprised subgroups of patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease. Patients were followed for 1 to 3 years.
19,185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years, with a mean follow-up of 1.91 years. There were 1960 first events included in the outcome cluster on which an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin. These rates reflect a statistically significant (p = 0.043) relative-risk reduction of 8.7% in favour of clopidogrel (95% Cl 0.3-16.5). Corresponding on-treatment analysis yielded a relative-risk reduction of 9.4%. There were no major differences in terms of safety. Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash (0.26% vs 0.10%), diarrhoea (0.23% vs 0.11%), upper gastrointestinal discomfort (0.97% vs 1.22%), intracranial haemorrhage (0.33% vs 0.47%), and gastrointestinal haemorrhage (0.52% vs 0.72%), respectively. There were ten (0.10%) patients in the clopidogrel group with significant reductions in neutrophils (< 1.2 x 10(9)/L) and 16 (0.17%) in the aspirin group.
Long-term administration of clopidogrel to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischaemic stroke, myocardial infarction, or vascular death. The overall safety profile of clopidogrel is at least as good as that of medium-dose aspirin.
CAPRIE was a randomised, blinded, international trial designed to assess the relative efficacy of clopidogrel (75 mg once daily) and aspirin (325 mg once daily) in reducing the risk of a composite outcome cluster of ischaemic stroke, myocardial infarction, or vascular death; their relative safety was also assessed. The population studied comprised subgroups of patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease. Patients were followed for 1 to 3 years.
19,185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years, with a mean follow-up of 1.91 years. There were 1960 first events included in the outcome cluster on which an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin. These rates reflect a statistically significant (p = 0.043) relative-risk reduction of 8.7% in favour of clopidogrel (95% Cl 0.3-16.5). Corresponding on-treatment analysis yielded a relative-risk reduction of 9.4%. There were no major differences in terms of safety. Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash (0.26% vs 0.10%), diarrhoea (0.23% vs 0.11%), upper gastrointestinal discomfort (0.97% vs 1.22%), intracranial haemorrhage (0.33% vs 0.47%), and gastrointestinal haemorrhage (0.52% vs 0.72%), respectively. There were ten (0.10%) patients in the clopidogrel group with significant reductions in neutrophils (< 1.2 x 10(9)/L) and 16 (0.17%) in the aspirin group.
Long-term administration of clopidogrel to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischaemic stroke, myocardial infarction, or vascular death. The overall safety profile of clopidogrel is at least as good as that of medium-dose aspirin.
Keywords
Adult, Arteriosclerosis/prevention & control, Aspirin/administration & dosage, Aspirin/adverse effects, Aspirin/therapeutic use, Brain Ischemia/prevention & control, Clopidogrel, Cohort Studies, Double-Blind Method, Female, Follow-Up Studies, Hemorrhage/chemically induced, Humans, Male, Myocardial Ischemia/prevention & control, Peripheral Vascular Diseases/prevention & control, Platelet Aggregation Inhibitors/administration & dosage, Platelet Aggregation Inhibitors/adverse effects, Platelet Aggregation Inhibitors/therapeutic use, Ticlopidine/administration & dosage, Ticlopidine/adverse effects, Ticlopidine/analogs & derivatives, Ticlopidine/therapeutic use, Treatment Outcome
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28/02/2008 12:59
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15/04/2023 6:51
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