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Search / Trial NCT06873321

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

Launched by SCIENCE VALLEY RESEARCH INSTITUTE · Mar 6, 2025

Trial Information

Current as of April 23, 2025

Recruiting

Keywords

Peripheral Arterial Disease Chronic Limb Threatening Ischemia Deep Vein Thrombosis Venous Thromboembolism Factor Xa Inhibitors Rivaroxaban

ClinConnect Summary

This clinical trial is studying the use of a medication called Rivaroxaban, combined with aspirin, to help prevent a serious condition known as venous thromboembolism (VTE) in patients who are having surgery to improve blood flow in their legs. VTE can happen when blood clots form in the veins and can lead to complications, especially in patients who have other health issues. The goal of the study is to see if using Rivaroxaban as a preventive measure is effective for patients undergoing these types of surgeries, which are often necessary for those with severe leg circulation problems.

To be eligible for this trial, participants should be adults of any age and gender who are scheduled for surgery to treat critical limb ischemia, a serious condition affecting blood flow to the legs. They will need to sign a consent form before participating. However, people who have had a recent clotting event or have certain health issues that prevent them from taking Rivaroxaban cannot participate. Those who join the study will be monitored closely and will need to return for a follow-up visit 30 days after their surgery to check on their recovery and the effectiveness of the treatment. This trial is currently looking for participants and aims to provide important information about the best ways to prevent blood clots after surgery.

Gender

ALL

Eligibility 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.

Trial Officials

Eduardo Ramacciotti, MD, Ph.D.

Study Director

Science Valley

About Science Valley Research Institute

Science Valley Research Institute is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a strong emphasis on scientific integrity and patient safety, the institute conducts a diverse range of clinical studies aimed at evaluating new therapies and medical interventions. Leveraging a multidisciplinary team of experts and state-of-the-art facilities, Science Valley Research Institute collaborates with pharmaceutical companies, academic institutions, and healthcare organizations to drive the discovery of effective treatments that address unmet medical needs. Committed to ethical standards and regulatory compliance, the institute plays a pivotal role in translating scientific breakthroughs into meaningful health solutions for patients worldwide.

Locations

Pernambuco, Pe, Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported