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

NCT06873321 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-12

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease
  • Venous Thormboembolism
  • Cardiovascular Diseases
  • Vascular Surgery Patient with PAD / Carotid Stenosis

Interventions

DRUG

rivaroxaban 2.5 mg bid + aspirin 100 mg

rivaroxaban 2.5 mg bid + aspirin

DRUG

clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures

comparator

Sponsors & Collaborators

  • Science Valley Research Institute

    lead OTHER

Principal Investigators

  • Eduardo Ramacciotti, MD, Ph.D. · Science Valley

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-24
Primary Completion
2025-07-20
Completion
2025-07-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873321 on ClinicalTrials.gov