Clinical trial Recruiting at 1 site Phase 4 Interventional

Evaluating VTE Prevention with Rivaroxaban and Aspirin After Lower Limb Surgery

Official title: 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

Run by Science Valley Research Institute · NCT06873321 · Data updated 2026-11-12

This study is testing if taking a combination of rivaroxaban and aspirin after lower limb surgery can help prevent blood clots better than just taking aspirin alone.

More Cardiovascular Diseases trials

Quick facts

PhasePhase 4
Study typeInterventional
SexAll
Enrollment100 (estimated)
SponsorScience Valley Research Institute
Academic / other
Locations1 site (Pernambuco, Pernambuco)
StatusRecruiting
StartedFebruary 24, 2024
Main results expectedJuly 20, 2025
Study endsJuly 30, 2025
Registry record updatedMarch 12, 2025
Trial IDNCT06873321 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults with critical limb ischemia who are scheduled for revascularization surgery.

Probably not a fit

Patients who have experienced a symptomatic VTE event during hospitalization or have contraindications to rivaroxaban may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the incidence of venous thromboembolism (VTE) in patients undergoing lower limb revascularization surgery. Participants will be treated with either rivaroxaban 2.5 mg twice daily combined with aspirin 100 mg or a single antiplatelet agent. The study will involve regular clinic visits for checkups and mandatory Doppler ultrasounds at 30 days post-surgery. The goal is to determine if the combination therapy reduces the incidence of VTE compared to standard treatment.

Why it matters

Potential benefit: If successful, this study could provide a more effective prophylactic treatment option for preventing VTE in patients undergoing lower limb revascularization.

How similar studies have gone: While there is ongoing debate regarding the use of DOACs for VTE prophylaxis in this context, similar studies have shown promising results with anticoagulant therapies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Hospital das Clínicas, Federal University of Pernambuco
    Pernambuco, Pernambuco, Brazil
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.