HealthyRivaMoS2NCT01710267
Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
An observational study of Healthy, run by Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male volunteers aged 18-65 years
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | This group includes all volunteers of this observation study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of RXA on trough and peak RXA conc. values in time
Measured: 14 days
Secondary outcomes (1)
Evaluation of the effect of RXA on coagulation assays in time
coagulation assays such as PT, PTT, individual coagulation factors, PiCT, ROTEM, multiplate
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland, Bayer
- Responsible party
- Sponsor-investigator, Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD, Luzerner Kantonsspital
- Investigators
- Walter A Wuillemin, MD PhD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710267
- Sponsor's protocol ID
- 12041
- Acronym
- RivaMoS2
- Status last verified
- Mar 2015
- First submitted
- 17 Oct 2012
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28574652Fontana 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.
PubMed 28343143
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
- ClinicalTrials.gov ID
- NCT01710267
- Acronym / sponsor ID
- RivaMoS2 / 12041
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhDUniversity, hospital or other
- Collaborators
- Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland, Bayer
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | –This group includes all volunteers of this observation study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male volunteers aged 18-65 years
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the effect of RXA on trough and peak RXA conc. values in time
Time frame: 14 days
1 secondary outcome
Evaluation of the effect of RXA on coagulation assays in time
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 28574652Studt 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.
- Derived from this study: PubMed 28343143Fontana 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.
- Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, SwitzerlandLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter A Wuillemin, MD PhD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of RXA on trough and peak RXA conc. values in time (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710267, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.