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

Publication ,  Journal Article
Ramacciotti, E; Agati, LB; Volpiani, GG; Brito, KF; Ribeiro, CM; Aguiar, VCR; Ramacciotti, LS; Paganotti, A; Pereira, FM; Caffaro, RA ...
Published in: Clin Appl Thromb Hemost
2022

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.

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Published In

Clin Appl Thromb Hemost

DOI

EISSN

1938-2723

Publication Date

2022

Volume

28

Start / End Page

10760296211073922

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Rivaroxaban
  • Prospective Studies
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Male
  • Intermittent Claudication
  • Humans
  • Follow-Up Studies
  • Female
 

Citation

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Ramacciotti, E., Agati, L. B., Volpiani, G. G., Brito, K. F., Ribeiro, C. M., Aguiar, V. C. R., … Lopes, R. D. (2022). Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial. Clin Appl Thromb Hemost, 28, 10760296211073922. https://doi.org/10.1177/10760296211073922
Ramacciotti, Eduardo, Leandro Barile Agati, Giuliano Giova Volpiani, Karen Falcão Brito, Camilla Moreira Ribeiro, Valéria Cristina Resende Aguiar, Lorenzo Storino Ramacciotti, et al. “Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial.Clin Appl Thromb Hemost 28 (2022): 10760296211073922. https://doi.org/10.1177/10760296211073922.
Ramacciotti E, Agati LB, Volpiani GG, Brito KF, Ribeiro CM, Aguiar VCR, et al. Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial. Clin Appl Thromb Hemost. 2022;28:10760296211073922.
Ramacciotti, Eduardo, et al. “Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial.Clin Appl Thromb Hemost, vol. 28, 2022, p. 10760296211073922. Pubmed, doi:10.1177/10760296211073922.
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. Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial. Clin Appl Thromb Hemost. 2022;28:10760296211073922.
Journal cover image

Published In

Clin Appl Thromb Hemost

DOI

EISSN

1938-2723

Publication Date

2022

Volume

28

Start / End Page

10760296211073922

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Rivaroxaban
  • Prospective Studies
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Male
  • Intermittent Claudication
  • Humans
  • Follow-Up Studies
  • Female