Observational study on patients with symptomatic peripheral artery disease using rivaroxaban and aspirin

PRospective Observational Study on PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS)

This study is testing if taking a combination of rivaroxaban and aspirin helps people with peripheral artery disease stick to their treatment plan and stay safe over a year.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituti Clinici Scientifici Maugeri SpA (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT06239415 on ClinicalTrials.gov

What this trial studies

This observational, prospective, multicenter study focuses on patients with symptomatic peripheral atherosclerotic disease in the lower limbs, with or without chronic ischemic heart disease. Participants will be treated with a combination of rivaroxaban 2.5 mg twice daily and acetylsalicylic acid (ASA) 100 mg. The study aims to evaluate patient adherence to this treatment regimen at 3 and 12 months, while also monitoring any adverse events that may arise during the study period. This research addresses a gap in real-world data regarding the effectiveness and adherence to this therapeutic strategy.

Who should consider this trial

Good fit: Ideal candidates include patients with symptomatic peripheral atherosclerotic disease of the lower extremities who can provide informed consent.

Not a fit: Patients requiring dual antiplatelet therapy or those with contraindications to rivaroxaban or aspirin may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment adherence and outcomes for patients with peripheral artery disease.

How similar studies have performed: While similar studies have explored antithrombotic strategies, this specific combination therapy's adherence and effectiveness in real-world settings remains largely untested.

Eligibility criteria

Inclusion Criteria:

* Patients with symptomatic peripheral atherosclerotic disease of the lower extremity
* Ability to provide written informed consent.

Exclusion Criteria:

* Need for dual antiplatelet therapy, or therapy with antiplatelet agents other than aspirin or oral anticoagulant therapy (full dose)
* Ischemic stroke within the previous 1 month or any history of hemorrhagic or lacunar stroke
* Dialysis or estimated glomerular filtration rate \<15 mL/min
* Known non-cardiovascular disease associated with poor prognosis (e.g. metastatic cancer)
* History of known hypersensitivity to rivaroxaban, aspirin or excipients
* Presence of contraindications to rivaroxaban and/or aspirin (as indicated in the technical data sheet)
* Systemic treatment with strong inhibitors of CYP 3A4 or p-glycoprotein (e.g. systemic antifungals, such as ketoconazole and human immunodeficiency virus \[HIV\] protease inhibitors, such as ritonavir) or strong inducers of CYP 3A4, e.g. Rifampicin, Rifabutin, Phenobarbital, Phenytoin and Carbamazepine
* Any liver disease associated with coagulopathy
* Subjects who are pregnant, breastfeeding or potentially pregnant, or of childbearing age, sexually active and not practicing an effective method of birth prevention (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, patch contraceptive, sterilization of the male partner)

Where this trial is running

Milan

• Istituti Clinici Scientifici Maugeri — Milan, Italy (Recruiting)

Study contacts

• Study coordinator: Laura Adelaide Dalla Vecchia, MD

Conditions Peripheral Atherosclerotic Disease