NCT06873321 VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization
| NCT ID | NCT06873321 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Science Valley Research Institute |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-24 |
| Primary Completion | 2025-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-02-24 with a primary completion date of 2025-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 anticoagulants (DOACs) is necessary. Currently, there is no consensus in the literature regarding the use of DOACs for extended VTE prophylaxis in patients undergoing lower limb revascularization (LLR). Objective: To evaluate the use of DOACs (already approved to reduce MACE and MALE) in VTE prophylaxis in patients undergoing LLR.
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.
Contact & Investigator
Eduardo Ramacciotti, MD, Ph.D.
STUDY DIRECTOR
Science Valley
Frequently Asked Questions
Who can join the NCT06873321 clinical trial?
This trial is open to participants of all sexes, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06873321 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06873321 currently recruiting?
Yes, NCT06873321 is actively recruiting participants. Contact the research team at gabriela.buril@ufpe.br for enrollment information.
Where is the NCT06873321 trial being conducted?
This trial is being conducted at Pernambuco, Brazil.
Who is sponsoring the NCT06873321 clinical trial?
NCT06873321 is sponsored by Science Valley Research Institute. The principal investigator is Eduardo Ramacciotti, MD, Ph.D. at Science Valley. The trial plans to enroll 100 participants.