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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Objective: To evaluate the use of DOACs (already approved to reduce MACE and MALE) in VTE prophylaxis in patients undergoing LLR.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Brazil
Hospital das Clínicas, Federal University of Pernambuco
RECRUITING
Pernambuco
Contact Information
Primary
Gabriela Oliveira Buril, MD
gabriela.buril@ufpe.br
+5581991121872
Time Frame
Start Date: 2024-02-24
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 100
Treatments
Experimental: study arm
Rivaroxaban 2.5 mg bid + aspirin 100 mg
Active_comparator: comparator
clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures
Related Therapeutic Areas
Sponsors
Leads: Science Valley Research Institute