Evaluating VTE Prevention with Rivaroxaban and Aspirin After Lower Limb Surgery
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
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 |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Science Valley Research Institute Academic / other |
| Locations | 1 site (Pernambuco, Pernambuco) |
| Trial ID | NCT06873321 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with critical limb ischemia who are scheduled for revascularization surgery.
Not a fit: Patients who have experienced a symptomatic VTE event during hospitalization or have contraindications to rivaroxaban may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pernambuco, Pernambuco
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.