Healthy Clinical Trial
Official title:
Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied
for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA
is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and
for prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.
This is an explorative laboratory study to evaluate the intra-individual variability of RXA
conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied
for prophylaxis of venous thromboembolism (VTE) after major orthopedic surgery of the lower
limbs such as hip and knee replacement surgery. Additionally, RXA is approved by Swissmedic
to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of
cerebrovascular events in non-valvular atrial fibrillation.
Monitoring of RXA concentration (conc.) is generally not required because of its stable
pharmacokinetic and pharmacodynamic profile, even in patients with renal insufficiency.
However, there are several clinical situations, in which it may be desirable to measure the
RXA plasma conc. The range of RXA conc. is wide among individuals with typical peak levels
of median 244 µg/L (IQR 175-360) and trough levels of median 32 µg/L (IQR 19-60) with once
daily doses of 20 mg RXA.
This is an explorative laboratory study to evaluate the intra-individual variability of RXA
conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
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Observational Model: Cohort, Time Perspective: Prospective
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