Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel

Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patie...

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Bibliographic Details
Published in:	Journal of the American College of Cardiology 2020-09, Vol.76 (12), p.1468-1483
Main Authors:	Capodanno, Davide, Morice, Marie-Claude, Angiolillo, Dominick J, Bhatt, Deepak L, Byrne, Robert A, Colleran, Roisin, Cuisset, Thomas, Cutlip, Donald, Eerdmans, Pedro, Eikelboom, John, Farb, Andrew, Gibson, C Michael, Gregson, John, Haude, Michael, James, Stefan K, Kim, Hyo-Soo, Kimura, Takeshi, Konishi, Akihide, Leon, Martin B, Magee, P F Adrian, Mitsutake, Yoshiaki, Mylotte, Darren, Pocock, Stuart J, Rao, Sunil V, Spitzer, Ernest, Stockbridge, Norman, Valgimigli, Marco, Varenne, Olivier, Windhovel, Ute, Krucoff, Mitchel W, Urban, Philip, Mehran, Roxana
Format:	Article
Language:	eng
Subjects:	Clinical Trials as Topic Hemorrhage high bleeding risk Humans Outcome Assessment, Health Care Percutaneous Coronary Intervention trial design
Online Access:	Get full text
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Summary:	Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.
ISSN:	0735-1097 1558-3597 1558-3597