The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Aug 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the drug rivaroxaban can help improve symptoms for people with Peripheral Arterial Disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to the limbs, which can cause pain and other issues. The goal of this study is to see if rivaroxaban can reduce blood clots and improve blood flow, thereby helping patients feel better. The trial is currently recruiting participants who have a history of PAD and are already taking aspirin.

To be eligible for this study, participants must have had certain medical treatments for PAD, such as surgery or procedures to restore blood flow, or have specific measurements that indicate PAD. However, people with a high risk of bleeding or certain serious health conditions may not be able to join. Those who participate can expect to receive the study drug and regular check-ups to monitor their health. If you or a loved one has PAD and is interested in learning more about this trial, it could be a chance to help improve treatment options for this condition.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• History of peripheral artery disease (PAD) defined as:
• • Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac or infra-inguinal arteries, or
• • Previous limb or foot amputation for arterial vascular disease, or
• • An ankle/arm blood pressure (BP) ratio less than 0.90, or
• • Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound, or
• • An ankle-brachial index (ABI) greater than 1.4 with a toe-brachial index (TBI) less than 0.7 AND
• • Willing and able to provide written informed consent
• • Receiving aspirin therapy prior to enrollment
• Exclusion Criteria:
• • High risk of bleeding
• • Stroke within 1 month of any history of hemorrhagic or lacunar stroke
• • Severe heart failure with known ejection fraction less than 30% or New York Heart Association (NYHA) class III or IV symptoms
• • Estimated glomerular filtration rate less than 15 mL/min/1.73m2
• • Need for dual-antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
• • Known non-cardiovascular disease that is associated with poor prognosis (e.g. metastatic cancer) or that increases the risk of an adverse reaction to study interventions
• • History of hypersensitivity or known contraindication to rivaroxaban or aspirin
• • Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (e.g. systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus \[HIV\]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
• • Any known hepatic disease associated with coagulopathy
• • Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control (e.g. surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, double- barrier method, contraceptive patch, male partner sterilization)
• • Concomitant participation in another study with investigational drug
• • Upcoming invasive procedure within 3 months
• • Invasive procedure within the prior 1 month
• • Being treated for an active infection
• • Acute or chronic limb-threatening ischemia
• • Known contraindication to any study related procedures