Status:
RECRUITING
VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization
Lead Sponsor:
Science Valley Research Institute
Conditions:
Peripheral Arterial Disease
Venous Thormboembolism
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures. Sometimes, extended prophylaxis for VTE with KLMWH or direct oral ant...
Detailed Description
The goal of this clinical trial is to evaluate the 30-day VTE incidence in patients submitted to endovascular or open surgery for lower limbs revascularization treated with either rivaroxaban 2.5 mg b...
Eligibility Criteria
Inclusion
- Be adults of any age and gender.
- Have critical limb ischemia with a proposed revascularization treatment (either via ATP or bypass surgery) at the Vascular Surgery Service of HC/EBSERH - UFPE.
- Sign the informed consent form (ICF) (Appendix 2).
Exclusion
- Experience a symptomatic VTE event during hospitalization, as they will require full anticoagulation rather than prophylactic anticoagulation.
- Have any contraindications to Rivaroxaban.
- Do not return for the 30-day postoperative follow-up visit.
Key Trial Info
Start Date :
February 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06873321
Start Date
February 24 2024
End Date
July 30 2025
Last Update
March 12 2025
Active Locations (1)
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1
Hospital das Clínicas, Federal University of Pernambuco
Pernambuco, Pernambuco, Brazil, 50740-900