Inaja

Researchers are evaluating the use of direct oral anticoagulants (DOACs), specifically rivaroxaban combined with aspirin, to prevent venous thromboembolism (VTE) in patients undergoing lower limb revascularization surgeries. This study focuses on patients with peripheral arterial disease and multiple health conditions who require complex vascular surgery, aiming to find out if rivaroxaban plus aspirin reduces the incidence of VTE within 30 days after surgery compared to standard single antiplatelet treatments. The trial is a Phase 4, single-center randomized clinical study conducted at the Hospital das Clínicas/Brazilian Hospital Services Company-Federal University of Pernambuco (HC/EBSERH-UFPE). Participants will be randomly assigned to either the study group receiving rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily, or the control group receiving standard care: aspirin 100 mg once daily alone for bypass surgery patients or aspirin combined with clopidogrel 75 mg once daily for three months followed by aspirin for angioplasty patients. Treatments will be given continuously, and randomization is managed through the REDCap platform. Due to the nature of the interventions, blinding is not possible. During the 30-day study period, participants will have clinic visits every two weeks for checkups and tests including a mandatory Doppler ultrasound at day 30. They will keep a diary of symptoms, and researchers will monitor safety and effectiveness primarily by measuring the incidence of VTE. The total study sample is about 200 patients, with 100 in each group, and the trial will assess both efficacy and safety outcomes at 30 days post-surgery.