RESUMEN
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 2.5â mg twice daily plus aspirin 100â mg once daily or aspirin 100â mg once daily for 24 weeks. The primary outcome is the change in claudication distance from the baseline to 24 weeks, measured by 6â 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.
Asunto(s)
Aspirina/uso terapéutico , Claudicación Intermitente/tratamiento farmacológico , Enfermedad Arterial Periférica/tratamiento farmacológico , Método Doble Ciego , Quimioterapia Combinada , Prueba de Esfuerzo , Inhibidores del Factor Xa/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Claudicación Intermitente/diagnóstico , Claudicación Intermitente/etiología , Masculino , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Estudios Prospectivos , Rivaroxabán/uso terapéutico , Resultado del TratamientoRESUMEN
This practical guidance, endorsed by the Brazilian Society of Thrombosis and Hemostasis and The Brazilian Society of Angiology and Vascular Surgery, the International Union of Angiology and the European Venous Forum, aims to provide physicians with clear guidance, based on current best evidence-based data, on clinical strategies to manage antithrombotic strategies in patients with coronavirus disease 2019.