Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol.
AuthorPellegrini, Vincent D
Eikelboom, John William
Evarts, C McCollister
Franklin, Patricia D
Garvin, Kevin L
Goldhaber, Samuel Z
Lambourne, Carol Ann
PublisherBMJ Publishing Group
MetadataShow full item record
AbstractPulmonary 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 itemhttp://hdl.handle.net/10713/18205
- Rivaroxaban for the prevention of venous thromboembolism: a single technology appraisal.
- Authors: Stevenson M, Scope A, Holmes M, Rees A, Kaltenthaler E
- Issue date: 2009 Oct
- Anticoagulants (extended duration) for prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair.
- Authors: Forster R, Stewart M
- Issue date: 2016 Mar 30
- Clinical Effectiveness and Safety of Aspirin for Venous Thromboembolism Prophylaxis After Total Hip and Knee Replacement: A Systematic Review and Meta-analysis of Randomized Clinical Trials.
- Authors: Matharu GS, Kunutsor SK, Judge A, Blom AW, Whitehouse MR
- Issue date: 2020 Mar 1
- CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.
- Authors: Sidhu VS, Graves SE, Buchbinder R, Naylor JM, Pratt NL, de Steiger RS, Chong BH, Ackerman IN, Adie S, Harris A, Hansen A, Cripps M, Lorimer M, Webb S, Clavisi O, Griffith EC, Anandan D, O'Donohue G, Kelly TL, Harris IA
- Issue date: 2019 Nov 6
- Aspirin versus enoxaparin for the initial prevention of venous thromboembolism following elective arthroplasty of the hip or knee: A systematic review and meta-analysis.
- Authors: Farey JE, An VVG, Sidhu V, Karunaratne S, Harris IA
- Issue date: 2021 Feb