Clinical trial NCT01710267: Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
Official title: Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland
name: Bayer
First posted: 2012-10-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male volunteers aged 18-65 years

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Male, aged 18-65 years

* No known comorbidity or disease
* No known galactose intolerance, lactase deficiency or glucose galactose malabsorption
* Taking no other medicaments
* No history for disorders regarding hemostasis
* Initial screening laboratory test showing normal values for liver/pancreas function (ALAT,ASAT,gGT, alkalic phosphatase, bilirubin, amylase, lipase), kidney function (creatinine), hematogram (white blood cell count, hemoglobin, platelet count), and coagulation parameters ("Gerinnungsstatus" with PT, aPTT, fibrinogen, thrombin time)
* written informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Evaluation of the effect of RXA on trough and peak RXA conc. values in time
timeFrame: 14 days
Secondary outcomes:
measure: Evaluation of the effect of RXA on coagulation assays in time
timeFrame: 14 days
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
state: LU
Study officials:
affiliation: Luzerner Kantonsspital
name: Walter A Wuillemin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Studt JD, Alberio L, Angelillo-Scherrer A, Asmis LM, Fontana P, Korte W, Mendez A, Schmid P, Stricker H, Tsakiris DA, Wuillemin WA, Nagler M. Accuracy and consistency of anti-Xa activity measurement for determination of rivaroxaban plasma levels. J Thromb Haemost. 2017 Aug;15(8):1576-1583. doi: 10.1111/jth.13747. Epub 2017 Jul 17.
citation: Fontana P, Alberio L, Angelillo-Scherrer A, Asmis LM, Korte W, Mendez A, Schmid P, Stricker H, Studt JD, Tsakiris DA, Wuillemin WA, Nagler M. Impact of rivaroxaban on point-of-care assays. Thromb Res. 2017 May;153:65-70. doi: 10.1016/j.thromres.2017.03.019. Epub 2017 Mar 21.