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

RecruitingPhase 4Ages any - anyAllScience Valley Research Institute
NCT06873321 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • 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
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Where

1 site
Hospital das Clínicas, Federal University of Pernambuco
Pernambuco, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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