The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease
NCT ID: NCT05009862
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2022-04-19
2026-03-01
Brief Summary
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Detailed Description
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Aim 1: To assess the impact of rivaroxaban on macrovascular endothelial function in a randomized, double-blind, placebo-controlled crossover intervention in humans with PAD.
Aim 2: To assess the impact of rivaroxaban on PAR-1-mediated platelet activation in addition to its pleiotropic effects on thrombosis, thrombolysis, and inflammation in a randomized, double-blind, placebo-controlled crossover intervention in humans with PAD.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Control
Participants will receive 81mg daily of aspirin + placebo for 30 days.
Placebo
placebo
Aspirin 81Mg Ec Tab
aspirin 81 milligrams
Intervention
Participants will receive 81mg of aspirin + rivaroxaban 2.5mg twice daily for 30 days.
Rivaroxaban 2.5 Mg Oral Tablet
rivaroxaban 2.5 milligrams twice daily
Aspirin 81Mg Ec Tab
aspirin 81 milligrams
Interventions
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Rivaroxaban 2.5 Mg Oral Tablet
rivaroxaban 2.5 milligrams twice daily
Placebo
placebo
Aspirin 81Mg Ec Tab
aspirin 81 milligrams
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Aaron W. Aday, MD, MSc
Assistant Professor Division of Cardiovascular Medicine
Principal Investigators
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Aaron W Aday, MD
Role: PRINCIPAL_INVESTIGATOR
VUMC Cardiovascular Medicine
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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200447
Identifier Type: -
Identifier Source: org_study_id