What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include anticoagulants like Rivaroxaban, antiplatelet agents, and statins. Anticoagulants, such as Rivaroxaban, can increase the risk of bleeding, including major bleeding events. Antiplatelet agents, like aspirin and ticagrelor, also carry a risk of bleeding and may cause gastrointestinal issues. Statins, used to manage cholesterol levels, can lead to muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. It is important for patients to discuss these potential side effects with their healthcare provider to manage risks effectively.

What prior FDA approvals exist?

For the treatment of Peripheral Arterial Disease (PAD), the FDA has approved several drugs, primarily focusing on antiplatelet and anticoagulant therapies. Antiplatelet agents like aspirin and clopidogrel are commonly used to reduce the risk of cardiovascular events. Cilostazol, a phosphodiesterase inhibitor, is approved to improve symptoms of intermittent claudication. While anticoagulants such as warfarin have been studied, they are not typically recommended due to the risk of major bleeding. Rivaroxaban, a Factor Xa inhibitor, is being studied for its potential benefits in PAD by preventing blood clots and improving symptoms, similar to other anticoagulants but with a potentially better safety profile.

What other types of research exist?

Promising novel alternatives to Rivaroxaban for PAD patients include: 1) Apixaban, which has shown efficacy in atrial fibrillation and may be beneficial for PAD; 2) Betrixaban, which has been studied for stroke prevention in atrial fibrillation and could be considered for PAD; 3) Vorapaxar, a PAR-1 antagonist that has shown benefits in reducing acute limb ischemia events in PAD patients. These alternatives should be discussed with a healthcare provider to determine the best treatment option.

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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

Must not have

Stroke within 1 month of any history of hemorrhagic or lacunar stroke

Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 37 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing a drug that prevents blood clots in patients with poor blood flow in their arteries. The drug works by blocking a protein that helps blood to clot, which may improve their symptoms. When combined with aspirin, it has shown significant benefits in reducing deaths and heart-related problems in these patients.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a stroke or a bleeding in the brain in the last month.

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My heart is very weak (EF<30%) or I have severe symptoms limiting my daily activities.

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I need medication to prevent blood clots.

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My kidney function is severely reduced.

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I am experiencing severe limb pain due to poor blood flow.

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I am at high risk for bleeding.

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I am not taking strong medication for fungal infections, HIV, or certain seizure disorders.

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I have a liver condition that affects my blood's ability to clot.

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I am currently receiving treatment for an infection.

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I have a serious health condition besides heart disease that could worsen with the study treatment.

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I am allergic to rivaroxaban or aspirin.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endogenous PAR-1 activation as measured by flow cytometry

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

Secondary study objectives

CD41a (Integrin alpha-II-beta)

CD62p (P-Selectin)

D-Dimer

+10 more

Other study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Aspirin 81Mg Ec Tab

2023

Completed Phase 4

~120

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Peripheral Arterial Disease (PAD) include anticoagulants like rivaroxaban, which inhibit Factor Xa to prevent blood clot formation, reducing the risk of major adverse limb and cardiovascular events. Antiplatelet agents, such as aspirin, prevent platelets from clumping together, thereby reducing the risk of arterial blockages. Statins lower cholesterol levels, which helps to slow the progression of atherosclerosis, a key factor in PAD. These treatments are vital for PAD patients as they improve blood flow, reduce the risk of clot-related complications, and enhance overall vascular health.

Medical Therapy for Secondary Prevention of Atherothrombotic Events in Peripheral Artery Disease.Prevention and Management of Urgent/Emergent Limb Ischemia.Rivaroxaban in patients with ischaemic chronic cardiomyopathy and obstructive peripheral arterial disease: rationale for treatment and results.