Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial

Concurrent cardiovascular disease and antiplatelet use (clopidogrel, prasugrel and ticagrelor) use poses a significant peri-endoscopic management challenge with a paucity of high-quality evidence available. Antiplatelet temporary interruption places patients at risk of serious cardiovascular thrombo...

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Main Authors: Shara Ket, Andrew Metz, Alan Moss, Ravinder Ogra, William Tam, Robyn Secomb, John Reynolds, Peter R. Gibson, Gregor Brown
Format: Article
Language:English
Published: Elsevier 2019-12-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865419302418
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spelling doaj-5e18014602704372838063da5599a1fb2020-11-25T00:57:42ZengElsevierContemporary Clinical Trials Communications2451-86542019-12-0116Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trialShara Ket0Andrew Metz1Alan Moss2Ravinder Ogra3William Tam4Robyn Secomb5John Reynolds6Peter R. Gibson7Gregor Brown8Department of Gastroenterology, Alfred Hospital and Monash University, Victoria, Australia; Corresponding author. Department of Gastroenterology and Hepatology, The Alfred Hospital, Melbourne, Australia, 3004.Department of Gastroenterology, Melbourne Health, Victoria, AustraliaDepartment of Endoscopic Services, Western Health, Melbourne, Australia; Department of Medicine – Western Health, Melbourne Medical School, The University of Melbourne, Victoria, AustraliaMiddlemore Hospital, Auckland, New ZealandRoyal Adelaide Hospital, South Australia, Australia; University of Adelaide, Australia; Calvary North Adelaide Hospital, South Australia, AustraliaDepartment of Gastroenterology, Alfred Hospital and Monash University, Victoria, AustraliaBiostatistics Consulting Platform, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, AustraliaDepartment of Gastroenterology, Alfred Hospital and Monash University, Victoria, AustraliaDepartment of Gastroenterology, Alfred Hospital and Monash University, Victoria, Australia; Epworth Health, Richmond, Victoria, AustraliaConcurrent cardiovascular disease and antiplatelet use (clopidogrel, prasugrel and ticagrelor) use poses a significant peri-endoscopic management challenge with a paucity of high-quality evidence available. Antiplatelet temporary interruption places patients at risk of serious cardiovascular thrombotic events. Continuing these agents potentially increases the risk of procedure related bleeding however this risk could be sufficiently mitigated by cold snare polypectomy and endoscopic clipping to manage intraprocedural bleeding, making routine colonoscopy on continued antiplatelet agents safe.The EPOC trial will examine whether continuation of antiplatelet therapy (clopidogrel, prasugrel or ticagrelor) as single or dual therapy with aspirin, is inferior or superior to temporary interruption of antiplatelet therapy, current standard of care, with regard to the use of endoscopic rescue clips or clinically significant post-polypectomy bleeding after cold snare polypectomy of polyps ≤10 mm. EPOC is a parallel group, proceduralist-blinded randomized controlled trial comparing recruiting patients on antiplatelet therapy undergoing elective colonoscopy.This trial is underway throughout Australia and New Zealand with a view to expanding to additional sites. 496 subjects in each arm are required for this study. EPOC is the first randomised controlled trial comparing temporary interruption with continuation of antiplatelet therapy in patients undergoing elective colonoscopy. Keywords: Clopidogrel, Prasugrel, Ticagrelor, Antiplatelet, Thienopyridine, Colonoscopy, Polypectomy, Bleedinghttp://www.sciencedirect.com/science/article/pii/S2451865419302418
collection DOAJ
language English
format Article
sources DOAJ
author Shara Ket
Andrew Metz
Alan Moss
Ravinder Ogra
William Tam
Robyn Secomb
John Reynolds
Peter R. Gibson
Gregor Brown
spellingShingle Shara Ket
Andrew Metz
Alan Moss
Ravinder Ogra
William Tam
Robyn Secomb
John Reynolds
Peter R. Gibson
Gregor Brown
Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial
Contemporary Clinical Trials Communications
author_facet Shara Ket
Andrew Metz
Alan Moss
Ravinder Ogra
William Tam
Robyn Secomb
John Reynolds
Peter R. Gibson
Gregor Brown
author_sort Shara Ket
title Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial
title_short Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial
title_full Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial
title_fullStr Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial
title_full_unstemmed Study design of endoscopic polypectomy on clopidogrel (EPOC): A randomised controlled trial
title_sort study design of endoscopic polypectomy on clopidogrel (epoc): a randomised controlled trial
publisher Elsevier
series Contemporary Clinical Trials Communications
issn 2451-8654
publishDate 2019-12-01
description Concurrent cardiovascular disease and antiplatelet use (clopidogrel, prasugrel and ticagrelor) use poses a significant peri-endoscopic management challenge with a paucity of high-quality evidence available. Antiplatelet temporary interruption places patients at risk of serious cardiovascular thrombotic events. Continuing these agents potentially increases the risk of procedure related bleeding however this risk could be sufficiently mitigated by cold snare polypectomy and endoscopic clipping to manage intraprocedural bleeding, making routine colonoscopy on continued antiplatelet agents safe.The EPOC trial will examine whether continuation of antiplatelet therapy (clopidogrel, prasugrel or ticagrelor) as single or dual therapy with aspirin, is inferior or superior to temporary interruption of antiplatelet therapy, current standard of care, with regard to the use of endoscopic rescue clips or clinically significant post-polypectomy bleeding after cold snare polypectomy of polyps ≤10 mm. EPOC is a parallel group, proceduralist-blinded randomized controlled trial comparing recruiting patients on antiplatelet therapy undergoing elective colonoscopy.This trial is underway throughout Australia and New Zealand with a view to expanding to additional sites. 496 subjects in each arm are required for this study. EPOC is the first randomised controlled trial comparing temporary interruption with continuation of antiplatelet therapy in patients undergoing elective colonoscopy. Keywords: Clopidogrel, Prasugrel, Ticagrelor, Antiplatelet, Thienopyridine, Colonoscopy, Polypectomy, Bleeding
url http://www.sciencedirect.com/science/article/pii/S2451865419302418
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