Rivaroxaban Laboratory Monitoring in Switzerland 2: Thera... | NCT01710267

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

NCT01710267

Sponsor

Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD

Status

Completed

Last Update Posted

Apr 1, 2015Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 17, 2012

First Submission Date that Met QC Criteria

Oct 17, 2012

First Posted Date

Oct 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2015

Last Update Posted Date

Apr 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD, Chief, Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland, Luzerner KantonsspitalSponsor-Investigator

Lead Sponsor

Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhDOTHER

Collaborators

Name	Class
Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland	UNKNOWN
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation group		This group includes all volunteers of this observation study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy male volunteers aged 18-65 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walter A Wuillemin, MD PhD	Luzerner Kantonsspital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Luzerner Kantonsspital		Lucerne	Canton of Lucerne	6000	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28574652	Derived	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.
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