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Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI

Abstract : 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. (C) 2020 by the American College of Cardiology Foundation.
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Submitted on : Thursday, March 11, 2021 - 10:46:42 AM
Last modification on : Thursday, March 11, 2021 - 8:09:45 PM
Long-term archiving on: : Saturday, June 12, 2021 - 6:24:08 PM


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Davide Capodanno, Marie-Claude Morice, Dominick Angiolillo, Deepak Bhatt, Robert Byrne, et al.. Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI. Journal of the American College of Cardiology, Elsevier, 2020, 76 (12), pp.1468-1483. ⟨10.1016/j.jacc.2020.06.085⟩. ⟨hal-03156943⟩



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