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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pernambuco, Pe, Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported