RecruitingPhase 4NCT06873321

VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization

Incidence of Venous Thromboembolism After Lower Limb Revascularization in Patients Receiving Rivaroxaban 2.5 Mg Bid + Aspirin 100 Mg Versus Single Antiplatelet Treatment - a Randomized Clinical Trial

Sponsor

Science Valley Research Institute

Enrollment

100 participants

Start Date

Feb 24, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Peripheral Arterial Disease Venous Thormboembolism Vascular Surgery Patient with PAD / Carotid Stenosis

Summary

Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures. Sometimes, extended prophylaxis for VTE with KLMWH or direct oral anticoagulants (DOACs) is necessary. Currently, there is no consensus in the literature regarding the use of DOACs for extended VTE prophylaxis in patients undergoing lower limb revascularization (LLR). Objective: To evaluate the use of DOACs (already approved to reduce MACE and MALE) in VTE prophylaxis in patients undergoing LLR.

Eligibility

Inclusion Criteria3

Be adults of any age and gender.
Have critical limb ischemia with a proposed revascularization treatment (either via ATP or bypass surgery) at the Vascular Surgery Service of HC/EBSERH - UFPE.
Sign the informed consent form (ICF) (Appendix 2).

Exclusion Criteria3

Experience a symptomatic VTE event during hospitalization, as they will require full anticoagulation rather than prophylactic anticoagulation.
Have any contraindications to Rivaroxaban.
Do not return for the 30-day postoperative follow-up visit.

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