Clinical trial NCT06239415: PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS)
Official title: PRospective Observational Study on PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Atherosclerotic Disease
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Società Italiana Cardiologia Ospedalità Accreditata (SICOA)
First posted: 2024-02-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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)

Primary outcomes:
measure: Adherence to the prescribed medical treatment
timeFrame: 3 months
measure: Adherence to the prescribed medical treatment
timeFrame: 12 months
Secondary outcomes:
measure: Adverse event
timeFrame: 3 months
measure: Adverse event
timeFrame: 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituti Clinici Scientifici Maugeri
Study officials:
References: