Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2) (RivaMoS2)

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Switzerland
  • LU
    • Luzern, LU, Switzerland, 6000
      • Luzerner Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Healthy male volunteers aged 18-65 years

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observation group; This group includes all volunteers of this observation study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the effect of RXA on trough and peak RXA conc. values in time	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the effect of RXA on coagulation assays in time	coagulation assays such as PT, PTT, individual coagulation factors, PiCT, ROTEM, multiplate	14 days

Collaborators and Investigators

• Sponsor: Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD
• Collaborators: Bayer; Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland
• Investigators: Principal Investigator: Walter A Wuillemin, MD PhD, Luzerner Kantonsspital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 12041 (Registry Identifier: DAIDS-ES Registry Number)