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

Healthy Clinical Trial

— RivaMoS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710267
• Other study ID #: 12041
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: March 31, 2015
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern	LU

Sponsors (3)

Lead Sponsor	Collaborator
Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD	Bayer (Schweiz) AG, Switzerland, Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the effect of RXA on trough and peak RXA conc. values in time		14 days	No
Secondary	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	No

External Links

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