RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Be adults of any age and gender. 2. Have critical limb ischemia with a proposed revascularization treatment (either via ATP or bypass surgery) at the Vascular Surgery Service of HC/EBSERH - UFPE. 3. Sign the willing to sign a consent form form (ICF) (Appendix 2). Who Should NOT Join This Trial: 1. Experience a symptomatic VTE event during hospitalization, as they will require full anticoagulation rather than prophylactic anticoagulation. 2. Have any contraindications to Rivaroxaban. 3. Do not return for the 30-day postoperative follow-up visit. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Be adults of any age and gender. 2. Have critical limb ischemia with a proposed revascularization treatment (either via ATP or bypass surgery) at the Vascular Surgery Service of HC/EBSERH - UFPE. 3. Sign the informed consent form (ICF) (Appendix 2). Exclusion Criteria: 1. Experience a symptomatic VTE event during hospitalization, as they will require full anticoagulation rather than prophylactic anticoagulation. 2. Have any contraindications to Rivaroxaban. 3. Do not return for the 30-day postoperative follow-up visit.

Treatments Being Tested

DRUG

rivaroxaban 2.5 mg bid + aspirin 100 mg

rivaroxaban 2.5 mg bid + aspirin

DRUG

clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures

comparator

Locations (1)

Hospital das Clínicas, Federal University of Pernambuco

Pernambuco, Pernambuco, Brazil