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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Ramacciotti, E; Agati, LB; Volpiani, GG; Brito, KF; Ribeiro, CM; Aguiar, VCR; Ramacciotti, LS; Paganotti, A; Pereira, FM; Caffaro, RA; Fioranelli, A; Krakauer, R; Rached, HRS; Wolosker, N; Anand, SS; Eikelboom, JW; Lopes, RD

Published Date

  • 2022

Published In

Volume / Issue

  • 28 /

Start / End Page

  • 10760296211073922 -

PubMed ID

  • 35043716

Pubmed Central ID

  • PMC8796110

Electronic International Standard Serial Number (EISSN)

  • 1938-2723

Digital Object Identifier (DOI)

  • 10.1177/10760296211073922


  • eng

Conference Location

  • United States