Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial

Eduardo Ramacciotti, Leandro Barile Agati, Giuliano Giova Volpiani, Karen Falcão Brito, Camilla Moreira Ribeiro, Valéria Cristina Resende Aguiar, Lorenzo Storino Ramacciotti, Alexia Paganotti, Felipe Menegueti Pereira, Roberto Augusto Caffaro, Alexandre Fioranelli, Rogério Krakauer, Heron Rhydan Saad Rached, Nelson Wolosker, Sonia S Anand, John W Eikelboom, Renato Delascio Lopes, Eduardo Ramacciotti, Leandro Barile Agati, Giuliano Giova Volpiani, Karen Falcão Brito, Camilla Moreira Ribeiro, Valéria Cristina Resende Aguiar, Lorenzo Storino Ramacciotti, Alexia Paganotti, Felipe Menegueti Pereira, Roberto Augusto Caffaro, Alexandre Fioranelli, Rogério Krakauer, Heron Rhydan Saad Rached, Nelson Wolosker, Sonia S Anand, John W Eikelboom, Renato Delascio Lopes

Abstract

Background: The COMPASS trial demonstrated that in patients with peripheral arterial disease, the combination of rivaroxaban and aspirin compared with aspirin reduces the risk of major adverse limb events, but it is not known whether this combination can also improve symptoms in patients with intermittent claudication. The primary objective of this study is to evaluate the effect of the combination on claudication distance.

Study design: Eighty-eight patients with intermittent claudication will be randomized to receive rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once daily for 24 weeks. The primary outcome is the change in claudication distance from the baseline to 24 weeks, measured by 6 min walking test and treadmill test. The primary safety outcome is the incidence of major bleeding and clinically relevant non-major bleeding according to the International Society on Thrombosis and Hemostasis criteria.

Summary: The COMPASS CLAUDICATION trial will provide high-quality evidence regarding the effect of the combination of rivaroxaban and aspirin on claudication distance in patients with peripheral arterial disease.

Keywords: anticoagulation; direct oral anticoagulants; intermittent claudication; peripheral arterial disease; rivaroxaban.

Conflict of interest statement

Declaration of Conflicting Interests: ER reports grants and consulting fees from Bayer and Pfizer; grants from the Brazilian Ministry of Science and Technology; and personal fees from Aspen Pharma, Biomm Pharma, and Daiichi Sankyo, outside of the submitted work. SSA reports honoraria and consultancy fees from Bayer and Janssen. John Eikelboom has received honoraria and / or research funding from Bayer, BI, BMS, DSI, Janssen, Merck, Pfizer, and Servier. RDL reports grants and personal fees from Bristol Myers Squibb, Pfizer, GlaxoSmithKline, Medtronic PLC, and Sanofi; and personal fees from Amgen, Bayer, and Boehringer Ingelheim, outside of the submitted work. All other authors declare no competing interests.

Figures

Figure 1.
Figure 1.
Compass Claudication trial study design.

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