The clopidogrel after surgery for coronary artery disease CASCADE randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery NCT00228423Report as inadecuate




The clopidogrel after surgery for coronary artery disease CASCADE randomized controlled trial: clopidogrel and aspirin versus aspirin alone after coronary bypass surgery NCT00228423 - Download this document for free, or read online. Document in PDF available to download.

Current Controlled Trials in Cardiovascular Medicine

, 6:15

First Online: 11 October 2005Received: 03 October 2005Accepted: 11 October 2005DOI: 10.1186-1468-6708-6-15

Cite this article as: Kulik, A., Le May, M., Wells, G.A. et al. Trials 2005 6: 15. doi:10.1186-1468-6708-6-15

Abstract

BackgroundSaphenous 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.

MethodsPatients 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.

DiscussionThis 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.

Keywordscoronary artery bypass graft surgery antiplatelet therapy saphenous vein AbbreviationsCABG– coronary artery bypass graft surgery

CASCADE– Clopidogrel after Surgery for Coronary Artery Disease Trial

CBC– complete blood counts

IVUS– intravascular ultrasound

MI– myocardial infarction

OHI– University of Ottawa Heart Institute

OPCAB– off-pump coronary artery bypass graft surgery

RRR– relative risk reduction

SVG– saphenous vein graft

Electronic supplementary materialThe online version of this article doi:10.1186-1468-6708-6-15 contains supplementary material, which is available to authorized users.

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Author: Alexander Kulik - Michel Le May - George A Wells - Thierry G Mesana - Marc Ruel

Source: https://link.springer.com/







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