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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Atherosclerotic Disease
• Intervention / Treatment: Other: observation

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Laura Adelaide Dalla Vecchia, MD; Phone Number: +390250725120; Email: laura.dallavecchia@icsmaugeri.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Istituti Clinici Scientifici Maugeri
    • Contact: Laura Adelaide Dalla Vecchia, MD; Phone Number: +390250725120; Email: laura.dallavecchia@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the prescribed medical treatment	Adherence to the prescribed medical treatment measured by the Morisky Medication. Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.	3 months
Adherence to the prescribed medical treatment	Adherence to the prescribed medical treatment measured by the Morisky Medication Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Cardiovascular events, death	3 months
Adverse event	Cardiovascular events, death	12 months

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: Società Italiana Cardiologia Ospedalità Accreditata (SICOA)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 2605CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No