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

Authors :
Shara N. Ket
Gregor J. Brown
Peter R. Gibson
Andrew J. Metz
Robyn Secomb
Alan C. Moss
John V. Reynolds
William Tam
Ravinder Ogra
Source :
Contemporary Clinical Trials Communications, Vol 16, Iss, Pp-(2019), Contemporary Clinical Trials Communications
Publication Year :
2019
Publisher :
Elsevier BV, 2019.

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: Clopidogrel, Prasugrel, Ticagrelor, Antiplatelet, Thienopyridine, Colonoscopy, Polypectomy, Bleeding

Details

ISSN :
24518654
Volume :
16
Database :
OpenAIRE
Journal :
Contemporary Clinical Trials Communications
Accession number :
edsair.doi.dedup.....80deb218a8e0617b16fc105d51a210fe
Full Text :
https://doi.org/10.1016/j.conctc.2019.100479