Blood thinner combo tested for leg artery disease
NCT ID NCT05009862
First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times
Summary
This completed Phase 4 trial studied 60 people with peripheral artery disease (PAD) to see if adding low-dose rivaroxaban to aspirin improves blood vessel function and reduces clotting. Participants took either rivaroxaban plus aspirin or a placebo plus aspirin. The study measured changes in artery dilation and platelet activation using ultrasound and blood tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rivaroxaban (a blood thinner) plus aspirin
- What this could lead to
- If successful, this could show that low-dose rivaroxaban plus aspirin improves blood vessel health and reduces clotting risk in people with peripheral artery disease.
- What could go wrong
- This is a small, completed study (60 participants) looking at lab markers, not major clinical outcomes like heart attacks or amputations. Results may not translate to real-world benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
60 people
The number who actually took part.
- Started
-
Apr 2022
- Finished
-
Jul 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Peripheral arterial disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Smartwatch-Coached walking at home put to the test for leg artery disease
- Could pressing instead of plugging let patients walk sooner after leg artery procedures?
- Which artery plug works best? trial pits proglide against femoseal
- Can artery clearing for blocked legs be done without an overnight stay?
- AI plus ultrasound could catch heart and lung decline before it turns critical
- A window into living tissue: new sensor may spot dangerous oxygen drops during surgery