Recruiting PHASE4 Peripheral Arterial Disease

New treatment option for Peripheral Arterial Disease

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

ClinicalTrials.gov ID: NCT06873321

What this study is testing

What is rivaroxaban 2.5 mg bid + aspirin 100 mg?

rivaroxaban 2.5 mg bid + aspirin 100 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripheral arterial disease.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Adults

You may be able to join if

  • 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...
  • Sign the informed consent form (ICF) (Appendix 2).

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Pernambuco, Pernambuco, Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Pernambuco, Pernambuco, Brazil. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.