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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorScience Valley Research Institute

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • rivaroxaban 2.5 mg bid + aspirin 100 mg
  • clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures

Treatment groups

100 Participants
are divided into 2 treatment groups