Peripheral Atherosclerotic Disease Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
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| Recruiting |
NCT03044665 -
RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)
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N/A |