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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05009862
Other study ID # 200447
Secondary ID 1K23HL151871-01A
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 19, 2022
Est. completion date March 1, 2025

Study information

Verified date October 2023
Source Vanderbilt University Medical Center
Contact Paige V Yates, BS
Phone (615) 322-0930
Email paige.v.yates@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The Primary Investigator's central hypothesis is that activation of thrombotic pathways and downstream effectors of factor Xa signaling contribute to the development of PAD and its complications. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - History of peripheral artery disease (PAD) defined as: 1. Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac or infra-inguinal arteries, or 2. Previous limb or foot amputation for arterial vascular disease, or 3. History of one or more of the following: 1. An ankle/arm blood pressure (BP) ratio < 0.90, or 2. Significant peripheral artery stenosis (=50%) documented by angiography, or by duplex ultrasound - 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 <30% or New York Heart Association (NYHA) class III or IV symptoms - Estimated glomerular filtration rate <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

Study Design


Intervention

Drug:
Rivaroxaban 2.5 Mg Oral Tablet
rivaroxaban 2.5 milligrams twice daily
Placebo
placebo
Aspirin 81Mg Ec Tab
aspirin 81 milligrams

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelium-dependent, flow-mediated dilation (FMD) of the brachial artery FMD will be measured by forearm high-resolution ultrasonography after treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Primary Endogenous PAR-1 activation as measured by flow cytometry Endogenous PAR-1 activation, a novel marker of platelet activation, will be measured by flow cytometry, following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. The unit of measure will be relative fluorescence. Baseline to 37 days
Secondary Prothrombin time Prothrombin time will be measured using turbidimetric assays following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. The unit of measure will be in seconds. Baseline to 37 days
Secondary Partial thromboplastin time Partial thromboplastin time will be measured using turbidimetric assays following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. The unit of measure will be seconds. Baseline to 37 days
Secondary von Willebrand factor (vWF) Blood levels of von Willebrand factor will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary D-Dimer Blood levels of D-dimer will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary High-sensitivity C-reactive protein. Blood levels of high-sensitivity C-reactive protein will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. The unit of measure will be mg/L. Baseline to 37 days
Secondary Tumor necrosis factor-alpha Blood levels of tumor necrosis factor-alpha will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary Interleukin-1beta Blood levels of interleukin-1beta will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary Interleukin-6 Blood levels of interleukin-6 will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary Soluble intercellular adhesion molecule-1 (slCAM-1) Blood levels of soluble intercellular adhesion molecule-1 (slCAM-1) will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary Monocyte chemoattractant protein-1 (MCP-1) Blood levels of monocyte chemoattractant protein-1 (MCP-1) will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary Plasminogen activator inhibitor 1 (PAI-1) Blood levels of plasminogen activator inhibitor 1 (PAI-1) will be measured following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary CD41a (Integrin alpha-II-beta) CD41a, a marker of platelet activation, will be measured by flow cytometry following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
Secondary CD62p (P-Selectin) CD62p, a marker of platelet activation, will be measured by flow cytometry following treatment with low-dose rivaroxaban plus aspirin and compared to the baseline value following treatment with aspirin plus placebo. Baseline to 37 days
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