This trial is evaluating if rivaroxaban 2.5 mg BID and aspirin 100 mg OD compared to aspirin alone improves on intermittent claudication distance in PAD patients.
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 intermittent 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 baseline to 24 hours as measured by 6 minutes walking test and treadmill test. The main safety outcome is the incidence of major bleeding according to ISTH 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
oral anticoagulants plus antiplatelet agent
Hospital e Maternidade Christovão da Gama - Science Valley clinical site
Santo André, São Paulo, Brazil
Science Valley Research Institute
Santo André, São Paulo, Brazil
Change from baseline in the total walking distance (TWD) at week 24 in meters in the 6-Minute Walk Test (6MWT)
Time frame: 6 months
Change from baseline in the total walking distance (TWD) at week 24 in meters in the treadmill test (TMT)
Time frame: 6 months
Change from baseline in the Quality of Life Walking Impairment Questionnaire (WIQ) from at week 24
Time frame: 6 months
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