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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Science Valley Research Institute Academic / other |
| Locations | 1 site (Pernambuco, Pernambuco) |
| Status | Recruiting |
| Started | February 24, 2024 |
| Main results expected | July 20, 2025 |
| Study ends | July 30, 2025 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06873321 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
- Study coordinator: Gabriela Oliveira Buril, MD
- Email: gabriela.buril@ufpe.br
- Phone: +5581991121872
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.