Cargando…

The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]

BACKGROUND: Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery. The process of saphenous vein intimal hyperplasia begins just days after surgical revascularization, setting the stage for graft atherosclerotic disease and its sequalae. Clopidogrel improves...

Descripción completa

Detalles Bibliográficos
Autores principales: Kulik, Alexander, Le May, Michel, Wells, George A, Mesana, Thierry G, Ruel, Marc
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2005
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1282584/
https://www.ncbi.nlm.nih.gov/pubmed/16219100
http://dx.doi.org/10.1186/1468-6708-6-15
_version_ 1782126138944913408
author Kulik, Alexander
Le May, Michel
Wells, George A
Mesana, Thierry G
Ruel, Marc
author_facet Kulik, Alexander
Le May, Michel
Wells, George A
Mesana, Thierry G
Ruel, Marc
author_sort Kulik, Alexander
collection PubMed
description BACKGROUND: Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery. The process of saphenous vein intimal hyperplasia begins just days after surgical revascularization, setting the stage for graft atherosclerotic disease and its sequalae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following coronary artery bypass surgery. METHODS: Patients undergoing multi-vessel coronary artery bypass grafting and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for a one year duration starting on the day of surgery (as soon as postoperative bleeding has been excluded). At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The trial will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery. DISCUSSION: This trial is the first prospective human study that will address the question of whether clopidogrel therapy improves outcomes and reduces saphenous vein graft intimal hyperplasia following cardiac surgery. Should the combination of clopidogrel and aspirin reduce the process of vein graft intimal hyperplasia, the results of this study will help redefine modern antiplatelet management of coronary artery bypass patients.
format Text
id pubmed-1282584
institution National Center for Biotechnology Information
language English
publishDate 2005
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-12825842005-11-13 The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423] Kulik, Alexander Le May, Michel Wells, George A Mesana, Thierry G Ruel, Marc Curr Control Trials Cardiovasc Med Study Protocol BACKGROUND: Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery. The process of saphenous vein intimal hyperplasia begins just days after surgical revascularization, setting the stage for graft atherosclerotic disease and its sequalae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following coronary artery bypass surgery. METHODS: Patients undergoing multi-vessel coronary artery bypass grafting and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for a one year duration starting on the day of surgery (as soon as postoperative bleeding has been excluded). At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The trial will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery. DISCUSSION: This trial is the first prospective human study that will address the question of whether clopidogrel therapy improves outcomes and reduces saphenous vein graft intimal hyperplasia following cardiac surgery. Should the combination of clopidogrel and aspirin reduce the process of vein graft intimal hyperplasia, the results of this study will help redefine modern antiplatelet management of coronary artery bypass patients. BioMed Central 2005 2005-10-11 /pmc/articles/PMC1282584/ /pubmed/16219100 http://dx.doi.org/10.1186/1468-6708-6-15 Text en Copyright © 2005 Kulik et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Kulik, Alexander
Le May, Michel
Wells, George A
Mesana, Thierry G
Ruel, Marc
The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]
title The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]
title_full The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]
title_fullStr The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]
title_full_unstemmed The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]
title_short The clopidogrel after surgery for coronary artery disease (CASCADE) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [NCT00228423]
title_sort clopidogrel after surgery for coronary artery disease (cascade) randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery [nct00228423]
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1282584/
https://www.ncbi.nlm.nih.gov/pubmed/16219100
http://dx.doi.org/10.1186/1468-6708-6-15
work_keys_str_mv AT kulikalexander theclopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT lemaymichel theclopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT wellsgeorgea theclopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT mesanathierryg theclopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT ruelmarc theclopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT kulikalexander clopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT lemaymichel clopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT wellsgeorgea clopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT mesanathierryg clopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423
AT ruelmarc clopidogrelaftersurgeryforcoronaryarterydiseasecascaderandomizedcontrolledtrialclopidogrelandaspirinversusaspirinaloneaftercoronarybypasssurgerynct00228423