VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization
100 patients around the world
Available in Brazil
The goal of this clinical trial is to evaluate the 30-day VTE incidence in patients
submitted to endovascular or open surgery for lower limbs revascularization treated with
either rivaroxaban 2.5 mg bid + aspirin 100 mg or single antiplatelet agents (SoC). The
main questions it aims to answer are:
Does rivaroxaban 2.5 mg + aspirin reduce the incidence of 30-day VTE?
Researchers will compare rivaroxaban 2.5 mg bid + aspirin 100 mg to a single antiplatelet
agent to check comparative VTE incidence.
Participants will:
Take either rivaroxaban 2.5 mg bid + aspirin continuously or single antiplatelet agent
(clopidogrel for 3 months followed by aspirin 100 mg for endovascular procedures or
aspirin for oper procedures) Visit the clinic once every 2 weeks for checkups and tests,
and a mandatory Doppler ultrasound at day 30 Keep a diary of their symptoms
Study Population The study population will consist of patients hospitalized in the
vascular surgery ward at the Hospital das Clínicas/Brazilian Hospital Services
Company-Federal University of Pernambuco (HC/EBSERH-UFPE) who undergo arterial
revascularization surgery of the lower limbs (LL) via angioplasty (ATP) or bypass
surgery.
The study will determine the sample size by the criteria established by Resolution 466/12
of the National Health Council. The estimated sample size is 200 research participants,
with 100 in the study group and 100 in the control group. If the degree of dispersion is
high, the number of research participants may be adjusted.
Study Design A single-center randomized clinical trial. Randomization will be performed
using the REDCap platform. Due to the nature of the procedure, blinding will not be
possible.
Considering an acceptable margin of error (5%), a confidence level of 95%, and a
prevalence of 50% for venous diseases, with a heterogeneity level of 50%.
Selection of Research Participants The selection of research participants will follow
specific inclusion and exclusion criteria. After selection, participants will be randomly
assigned to the Study Group (SG) or the Control Group (CG).
CG (Control Group): Will receive standard treatment as described in the literature:
Aspirin (ASA) 100 mg once daily for patients undergoing lower limb bypass
revascularization, and ASA 100 mg once daily combined with Clopidogrel 75 mg once daily
for patients undergoing lower limb angioplasty.
SG (Study Group): Will receive ASA 100 mg once daily plus Rivaroxaban 2.5 mg twice daily
for patients undergoing bypass or angioplasty revascularization.
A total of 100 patients will be included in the study, equally divided between the
control and study groups. Randomization will be performed via the REDCap platform.
Science Valley Research Institute
1Research sites
100Patients around the world
This study is for people with
Cardiovascular disease
Venous disorders
Venous Thormboembolism
Requirements for the patient
All Gender
Medical requirements
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).
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.
Sites
Hospital das Clínicas Universidade Federal de Pernambuco - UFPE
Recruiting
Av. Prof. Moraes Rego, 1235 - Cidade Universitária, Recife - PE, 50670-901