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Contemp Clin Trials Commun. 2019 Nov 1;16:100479. doi: 10.1016/j.conctc.2019.100479. eCollection 2019 Dec.

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

Author information

1
Department of Gastroenterology, Alfred Hospital and Monash University, Victoria, Australia.
2
Department of Gastroenterology, Melbourne Health, Victoria, Australia.
3
Department of Endoscopic Services, Western Health, Melbourne, Australia.
4
Department of Medicine - Western Health, Melbourne Medical School, The University of Melbourne, Victoria, Australia.
5
Middlemore Hospital, Auckland, New Zealand.
6
Royal Adelaide Hospital, South Australia, Australia.
7
University of Adelaide, Australia.
8
Calvary North Adelaide Hospital, South Australia, Australia.
9
Biostatistics Consulting Platform, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.
10
Epworth Health, Richmond, Victoria, Australia.

Abstract

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:

Antiplatelet; Bleeding; Clopidogrel; Colonoscopy; Polypectomy; Prasugrel; Thienopyridine; Ticagrelor

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