Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol.
Author
Pellegrini, Vincent DEikelboom, John William
Evarts, C McCollister
Franklin, Patricia D
Garvin, Kevin L
Goldhaber, Samuel Z
Iorio, Richard
Lambourne, Carol Ann
Magaziner, Jay
Magder, Laurence
Date
2022-03-08Journal
BMJ OpenPublisher
BMJ Publishing GroupType
Article
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Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7-2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board.Rights/Terms
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Identifier to cite or link to this item
http://hdl.handle.net/10713/18205ae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2021-060000
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