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Anticoagulant

Rivaroxaban + Aspirin for Peripheral Artery Disease

Phase 4

Recruiting

Led By Aaron W Aday, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving aspirin therapy prior to enrollment

Previous limb or foot amputation for arterial vascular disease, or

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 37 days

Awards & highlights

Study Summary

This trial will help researchers understand how well the drug rivaroxaban works to improve symptoms in peripheral artery disease.

Who is the study for?

This trial is for adults with peripheral artery disease (PAD), evidenced by specific symptoms or past surgeries related to PAD. They must be taking aspirin and able to consent. Excluded are those in other drug studies, with recent or upcoming surgeries, severe heart failure, high bleeding risk, certain drug treatments (like strong CYP3A4 inhibitors/inducers), active infections, poor kidney function, serious non-cardiovascular diseases, known allergies to study drugs, liver issues affecting blood clotting, or women who could become pregnant without effective birth control.Check my eligibility

What is being tested?

The study tests if rivaroxaban can improve PAD symptoms compared to a placebo. Participants will also take low-dose aspirin. The goal is to see how rivaroxaban affects blood clots formation and the health of blood vessels and platelets.See study design

What are the potential side effects?

Rivaroxaban may cause bleeding problems since it's designed to prevent blood clots. It might also lead to digestive tract discomforts like stomach pain or indigestion due to its action on the body's clotting mechanisms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently taking aspirin.

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I have had a limb or foot amputated due to poor blood flow.

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I have a significant narrowing in my arteries.

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I have had surgery or a procedure to improve blood flow in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 37 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 37 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 37 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endogenous PAR-1 activation as measured by flow cytometry

Endothelium-dependent, flow-mediated dilation (FMD) of the brachial artery

Secondary outcome measures

CD41a (Integrin alpha-II-beta)

CD62p (P-Selectin)

D-Dimer

+10 more

Other outcome measures

Change in peripheral artery disease as measured by a 4-meter walk speed test

Change in peripheral artery disease as measured by a 6 minute walk test

Change in serum thromboxane B2 as measured by gas chromatography

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment2 Interventions

Participants will receive 81mg of aspirin + rivaroxaban 2.5mg twice daily for 30 days.

Group II: ControlPlacebo Group2 Interventions

Participants will receive 81mg daily of aspirin + placebo for 30 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rivaroxaban 2.5 Mg Oral Tablet

2020

Completed Phase 4

~290

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,118 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

732 Patients Enrolled for Peripheral Arterial Disease

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,519 Total Patients Enrolled

52 Trials studying Peripheral Arterial Disease

108,861 Patients Enrolled for Peripheral Arterial Disease

Aaron W Aday, MDPrincipal InvestigatorVUMC Cardiovascular Medicine

Media Library

Rivaroxaban 2.5 Mg Oral Tablet (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05009862 — Phase 4

Peripheral Arterial Disease Research Study Groups: Intervention, Control

Peripheral Arterial Disease Clinical Trial 2023: Rivaroxaban 2.5 Mg Oral Tablet Highlights & Side Effects. Trial Name: NCT05009862 — Phase 4

Rivaroxaban 2.5 Mg Oral Tablet (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05009862 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals are researchers hoping to achieve through this investigation?

"This clinical trial will observe changes in optical aggregation of platelets using tissue factor over a 37-day period. Secondary milestones include alterations to fibrinolysis, as evaluated via anti-factor Xa activity with results reported in units/mL of Xa activity; microvascular endothelial function measured pre and post reactive hyperemia using the EndoPAT 2000 software and expressed as a Reactive Hyperemia Index relative to baseline vascular tone; and finally, inflammation levels assessed through high sensitivity C-reactive protein testing with outcomes stated in mg/L."

Answered by AI

What is the aggregate amount of participants involved in this clinical experiment?

"Affirmative, the trial is still open to patients. Initially posted on April 19th 2022 and recently updated August 9th of this year, this clinical trial is searching for 75 individuals across a single site."

Answered by AI

What have been the primary applications of Rivaroxaban 2.5 Mg Oral Tablet?

"Rivaroxaban 2.5 Mg Oral Tablet is usually taken to manage pain, though it may also be prescribed for myocardial infarction, catarrh, and bone fractures."

Answered by AI

Is this medical trial pioneering a new approach to treatment?

"Since its first trial in 2005, which was sponsored by Abbott and included 15480 patients, Rivaroxaban 2.5 Mg Oral Tablet has been approved for Phase 4 drug use. Currently, there are 215 active studies concerning this medication being conducted across 60 countries and 1534 cities."

Answered by AI

Has registration for this research project begun?

"According to the listing on clinicaltrials.gov, this medical trial is actively searching for participants. It was first published in April of 2022 and its last amendment occurred in August 2022."

Answered by AI