Why the study?
Although dual pathway inhibition with rivaroxaban and aspirin demonstrated efficacy in polyvascular disease in the COMPASS trial, the underlying mechanism is not clearly understood.
Does aspirin plus rivaroxaban reduce platelet activation, aggregation, inflammation, and coagulation markers compared to aspirin alone in patients with coronary artery disease and peripheral artery disease?
Does aspirin plus rivaroxaban reduce platelet activation, aggregation, inflammation, and coagulation markers compared to aspirin alone in patients with coronary artery disease and peripheral artery disease?
This study protocol aims to elucidate the mechanistic effects of dual pathway inhibition with rivaroxaban and aspirin on coagulation and inflammation biomarkers in patients with polyvascular disease.
Answers are grounded in this paper and cite their sources.
Hypothesis-generating for rivaroxaban effects on biomarkers in polyvascular disease; leaves open translation to clinical outcomes.
COMPASS study demonstrated efficacy of dual pathway inhibition with 2.5 mg twice daily rivaroxaban and aspirin in patients with polyvascular disease (coronary artery disease, peripheral arterial disease or both), the underlying mechanism of which is not clearly understood. In this Phase IV, prospective, open-label and randomized study, we hypothesize that treatment with rivaroxaban is associated with a reduction in platelet activation and aggregation, inflammation and coagulation markers. 30 patients will be randomly treated with aspirin (81 mg q.d.) or aspirin plus rivaroxaban (2.5 mg b.i.d.) for 12 weeks. Platelet aggregation, platelet activation and inflammation markers, thrombin generation kinetics and tissue factor-induced platelet–fibrin clot strength will be measured at baseline, and 4 and 12 weeks after randomization. Trial registration number: NCT04059679
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Tantry et al. (2020) studied this question.
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