Examining how rivaroxaban affects blood flow and clotting in patients with peripheral artery disease
The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease
PHASE4 · Vanderbilt University Medical Center · NCT05009862
This study is testing if the blood thinner rivaroxaban can improve blood flow and reduce clotting in people with peripheral artery disease when taken alongside aspirin.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05009862 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of the anticoagulant drug rivaroxaban on patients with peripheral artery disease (PAD). It aims to determine how rivaroxaban influences macrovascular endothelial function and platelet activation through a randomized, double-blind, placebo-controlled crossover design. The study will assess both the direct effects on thrombosis and thrombolysis as well as the drug's impact on inflammation in individuals with PAD. Participants will receive either rivaroxaban or a placebo in conjunction with aspirin therapy.
Who should consider this trial
Good fit: Ideal candidates include individuals with a documented history of peripheral artery disease and currently receiving aspirin therapy.
Not a fit: Patients at high risk of bleeding or with severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from peripheral artery disease.
How similar studies have performed: Other studies have shown promising results with anticoagulants in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Aaron W Aday, MD — VUMC Cardiovascular Medicine
- Study coordinator: Paige V Yates, BS
- Email: paige.v.yates@vumc.org
- Phone: (615) 322-0930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Thrombosis, Rivaroxaban, Anticoagulant