The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function i… (NCT05009862) | Clinical Trial Compass
CompletedPhase 4
The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease
United States60 participantsStarted 2022-04-19
Plain-language summary
The purpose of this study is to understand how the drug rivaroxaban improves symptoms associated with peripheral artery disease.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immu…
What they're measuring
1
Endothelium-dependent, flow-mediated dilation (FMD) of the brachial artery
Timeframe: Baseline to 37 days
2
Endogenous PAR-1 activation as measured by flow cytometry