DUAL Pathway Inhibition to Improve Endothelial Function in Peripheral Artery Disease
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Peripheral artery disease (PAD) is a manifestation of systemic atherosclerosis, causing
patients to be at high risk of major adverse cardiovascular and limb events. Therefore,
single antiplatelet therapy is recommended when patients are symptomatic or have undergone
revascularization. Rivaroxaban (2.5 mg twice a day) in addition to Aspirin (100 mg once a
day) has shown to be effective in reducing morbidity and mortality from major cardiovascular
and limb events in patients with stable peripheral or carotid artery disease compared to
Aspirin alone. Although a higher rate of major bleeding was detected, the incidence of fatal
or critical organ bleedings was not increased.
Endothelial dysfunction is one of the first signs of atherosclerosis and is related to major
cardiovascular events. The level of vascular endothelial dysfunction can be measured using
the carotid artery reactivity (CAR) test. The investigators hypothesized that a combination
of low-dose rivaroxaban and antiplatelet therapy would improve endothelial function in PAD
patients.
The investigators aim to study the effectiveness of this combination therapy in improving
vascular endothelial function in patients with stable or symptomatic PAD.
Therefore the investigators will study two clinical cohorts of lower extremity PAD patients
(n=159) with intermittent claudication (group A: Fontaine stages 1-2) or critical limb
ischemia with pain at rest and/or foot ulcers (group B: Fontaine stages 3-4) who have an
indication for single antiplatelet therapy.
Aspirin 100mg once a day + 2.5 mg rivaroxaban twice a day will be given during 3 months,
preceded by a run-in period of Aspirin alone (100 mg once a day) as reference.
The change in proportion of patients with CAR-constriction from baseline (Aspirin alone) to 3
months after adding low dose rivaroxaban will be compared for both study groups (A and B).