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

NCT ID: NCT06239415

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2024-03-31

Brief Summary

The observational, prospective, multicenter study enrolls patients experiencing symptomatic peripheral atherosclerotic disease in the lower limb, with or without chronic ischemic heart disease, and who have an indication for treatment with rivaroxaban 2.5 mg twice daily and ASA 100 mg. The study's objective is to assess adherence to the prescribed treatment after 3 months and 12 months from enrollment, as well as to monitor any adverse events that may occur during this period.

Detailed Description

Life expectancy in patients suffering from chronic peripheral obstructive arterial disease is significantly reduced compared to their non-arteriopathic peers. Mortality 15 years after diagnosis of ACOP is approximately 70%. Literature studies showed that treatment with rivaroxaban 5 mg bid, compared to acetylsalicylic acid (ASA), caused a significant increase in bleeding, in the absence of a clear clinical benefit. Instead, the rivaroxaban 2.5bid-ASA combination strategy proved to be more effective than ASA monotherapy, in terms of a 24% reduction in the combined primary endpoint (cardiovascular death, myocardial infarction, stroke). On the basis of these results, the recent guidelines of the European Society of Cardiology on chronic coronary syndromes recommend, in secondary prevention, the addition of a second antithrombotic drug to ASA in patients with high (recommendation class IIa, level of evidence A) or moderate (class of recommendation IIb, level of evidence A) risk of ischemic events, in the absence of high bleeding risk. The choice of drug to combine with ASA falls on a P2Y12 platelet receptor inhibitor or an anticoagulant, i.e. rivaroxaban 2.5 mg.

However, the use of the association of an antiplatelet drug with a low-dose anticoagulant drug and adherence to this treatment has not yet been adequately evaluated in the real world. In fact, no Italian observational data relating to this therapeutic strategy are currently available.

The observational, prospective, multicenter study includes patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and ASA 100 mg. The aim of the study is to examine the adherence to the treatment prescriptions after 3 months and after 12 months the enrolment and possible adverse events occurred in this time period.

Conditions

Peripheral Atherosclerotic Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

observation

Observation for 1 year of patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and acetylsalicylic acid 100 mg.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Società Italiana Cardiologia Ospedalità Accreditata (SICOA)

UNKNOWN

Sponsor Role: collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Laura Adelaide Dalla Vecchia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istituti Clinici Scientifici Maugeri

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Laura Adelaide Dalla Vecchia, MD

Role: CONTACT

laura.dallavecchia@icsmaugeri.it

+390250725120

Facility Contacts

Laura Adelaide Dalla Vecchia, MD

Role: primary

laura.dallavecchia@icsmaugeri.it

+390250725120

Other Identifiers

2605CE

Identifier Type: -

Identifier Source: org_study_id