RecruitingPhase 4

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

Brazil100 participantsStarted 2024-02-24

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

primary efficacy outcome

Timeframe: 30 days

primary safety outcome

Timeframe: 30 days

Trial details

NCT IDNCT06873321

SponsorScience Valley Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-20

Contact for this trial

Gabriela Oliveira Buril, MD

+5581991121872 gabriela.buril@ufpe.br

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