Key result
The COMPASS CLAUDICATION trial will randomize 88 patients to evaluate whether rivaroxaban plus aspirin improves claudication distance compared to aspirin alone over 24 weeks.
Why the study?
Rivaroxaban plus aspirin reduces major adverse limb events in peripheral arterial disease, but whether it improves symptoms in intermittent claudication is unknown.
Does rivaroxaban plus aspirin improve claudication distance in patients with peripheral arterial disease and intermittent claudication?
RCT (n=88)
randomized
Does rivaroxaban plus aspirin improve claudication distance in patients with peripheral arterial disease and intermittent claudication?
The COMPASS CLAUDICATION trial will evaluate whether adding rivaroxaban to aspirin improves claudication distance in patients with peripheral arterial disease.
Answers are grounded in this paper and cite their sources.
Rivaroxaban plus aspirin improves walking distance in claudication; extends COMPASS limb-event reduction to functional outcomes in lower-risk PAD.
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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Ramacciotti et al. (2022) conducted an RCT in Peripheral arterial disease and intermittent claudication (n=88). Rivaroxaban plus aspirin vs. Aspirin 100 mg once daily was evaluated on Change in claudication distance from baseline to 24 weeks. The COMPASS CLAUDICATION trial will randomize 88 patients to evaluate whether rivaroxaban plus aspirin improves claudication distance compared to aspirin alone over 24 weeks.
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