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

Recruiting now · Phase 4

Conditions studied: Peripheral Arterial Disease, Venous Thormboembolism, Cardiovascular Diseases, Vascular Surgery Patient with PAD / Carotid Stenosis

In brief

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.

Key facts

Study ID

NCT06873321

Run by

Science Valley Research Institute

People needed

100

Starts

2024-02-24

Expected to finish

2025-07-30

Last updated by the study team

2025-03-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Hospital das Clínicas, Federal University of Pernambuco — Pernambuco, Pernambuco, Brazil (enrolling)

Full record on ClinicalTrials.gov

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