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COMPASS Cardiovascular Outcomes for People Using Anticoagulation Strategies

Official Title

Cardiovascular OutcoMes for People Using Anticoagulation StrategieS

Status

Ongoing

Overview

Randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with CAD or PAD. If participant not currently on PPI, randomization to pantoprazole/placebo for the reduction of gastrointestinal bleeding, ulceration, and gastrointestinal obstruction or perforation in subjects with CAD or PAD receiving antithrombotic medications.

Randomized trial is complete. Open label extension is ongoing.

Study Design

Randomized, blinded, partial factorial, 3×2, parallel group design, multicenter, event-driven study. All patients must successfully complete a 4-week run-in phase on low-dose of rivaroxaban prior to being randomized.

Primary Endpoint

Primary efficacy outcome: Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death, over approximately 5 years
Primary safety outcome: Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis), over approximately 5 years

Number of Patients

27395

Number of Sites

602

Number of Countries

33

Study Period

2013–2021

Principal Investigator

Stuart Connolly, John Eikelboom, Jackie Bosch

Program Manager

Gayle Lewis

Research Coordinator

Jane Belanger, Kevin Reeh, Kym Brettell

Collaborators

Bayer

Key Publications

Sonia S. Anand, John W. Eikelboom, Leanne Dyal, Jackie Bosch, Christoph Neumann, Petr Widimsky, Alvaro A. Avezum, Jeffrey Probstfield, Nancy Cook Bruns, Keith A.A. Fox, Deepak L. Bhatt, Stuart J. Connolly, Salim Yusuf and for the COMPASS Trial Investigators. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. JACC. 2019 July. DOI: 10.1016/j.jacc.2019.02.079.

Keith A.A. Fox, John W. Eikelboom, Olga Shestakovska, Stuart J. Connolly, Kaj P. Metsarinne and Salim Yusuf. Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction from the COMPASS Trial. JACC. 2019 May. DOI: 10.1016/j.jacc.2019.02.048.

Paul Moayyedi, John W. Eikelboom, Jackie Bosch, Stuart J. Connolly, Leanne Dyal, Olga Shestakovska, Darryl Leong, Sonia S. Anand, Stefan Störk, Kelly R.H. Branch, Deepak L. Bhatt, Peter B. Verhamme, Martin O’Donnell, Aldo P. Maggioni, Eva M. Lonn, Leopoldo S. Piegas, Georg Ertl, Matyas Keltai, Nancy Cook Bruns, Eva Muehlhofer, Gilles R. Dagenais, Jae-Hyung Kim, Masatsugu Hori, P. Gabriel Steg, Robert G. Hart, Rafael Diaz, Marco Alings, Petr Widimsky, Alvaro Avezum, Jeffrey Probstfield, Jun Zhu, Yan Liang, Patricio Lopez-Jaramillo, Ajay Kakkar, Alexander N. Parkhomenko, Lars Ryden, Nana Pogosova, Antonio Dans, Fernando Lanas, Patrick J. Commerford, Christian Torp-Pedersen, Tomek Guzik, Dragos Vinereanu, Andrew M. Tonkin, Basil S. Lewis, Camilo Felix, Khalid Yusoff, Kaj Metsarinne, Keith A.A. Fox, Salim Yusuf for the COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology J. 2019. DOI: 10.1053/j.gastro.2019.04.04.

Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lanius V, Yuan F, Misselwitz F, Chen E, Diaz R, Alings M, Lonn EM, Widimsky P, Hori M, Avezum A, Piegas LS, Bhatt DL, Branch KRH, Probstfield JL, Liang Y, Liu L, Zhu J, Maggioni AP, Lopez-Jaramillo P, O’Donnell M, Fox KAA, Kakkar A, Parkhomenko AN, Ertl G, Störk S, Keltai K, Keltai M, Ryden L, Dagenais GR, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Ha JW, Tonkin AM, Varigos JD, Lewis BS, Felix C, Yusoff K, Steg PG, Aboyans V, Metsarinne KP, Anand SS, Hart RG, Lamy A, Moayyedi P, Leong DP, Sharma M, Yusuf S. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial. Can J Cardiol. 2017 Aug;33(8):1027-1035. doi: 10.1016/j.cjca.2017.06.001. Epub 2017 Jun 8.

Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O’Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Störk S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.

Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk S, Zhu J, Lopez-Jaramillo P, O’Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10.

Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O’Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10.