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.
Patients with symptomatic peripheral atherosclerotic disease of the lower extremity
Ability to provide written informed consent.
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)
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PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS) 0 reviewsWrite Your Review
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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.