ACTIVE_NOT_RECRUITING

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

Conditions

Peripheral Arterial Disease Peripheral Artery Disease PAD Thrombosis Rivaroxaban Anticoagulant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to understand how the drug rivaroxaban improves symptoms associated with peripheral artery disease.

Official Title

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

Quick Facts

Study Start:2022-04-19

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05009862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Principal Investigator

Aaron W Aday, MD

PRINCIPAL_INVESTIGATOR

VUMC Cardiovascular Medicine

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Aaron W Aday, MD, PRINCIPAL_INVESTIGATOR, VUMC Cardiovascular Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-19

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2022-04-19

Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

Peripheral Artery Disease
PAD
Thrombosis
Rivaroxaban
Anticoagulant

Additional Relevant MeSH Terms

Peripheral Arterial Disease