Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-16 @ 3:34 PM
Study NCT ID:
NCT01710267
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2012-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples for coagulation assays'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-31', 'studyFirstSubmitDate': '2012-10-17', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the effect of RXA on trough and peak RXA conc. values in time', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the effect of RXA on coagulation assays in time', 'timeFrame': '14 days', 'description': 'coagulation assays such as PT, PTT, individual coagulation factors, PiCT, ROTEM, multiplate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28574652', 'type': 'DERIVED', '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.'}, {'pmid': '28343143', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.luks.ch/standorte/luzern/kliniken/medizin/haematologie.html', 'label': 'Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nMonitoring 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male volunteers aged 18-65 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale, aged 18-65 years\n\n* No known comorbidity or disease\n* No known galactose intolerance, lactase deficiency or glucose galactose malabsorption\n* Taking no other medicaments\n* No history for disorders regarding hemostasis\n* 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)\n* written informed consent\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01710267', 'acronym': 'RivaMoS2', 'briefTitle': 'Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)', 'organization': {'class': 'OTHER', 'fullName': 'Luzerner Kantonsspital'}, 'officialTitle': 'Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)', 'orgStudyIdInfo': {'id': '12041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation group', 'description': 'This group includes all volunteers of this observation study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Lucerne', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Walter A Wuillemin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luzerner Kantonsspital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland', 'investigatorFullName': 'Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD', 'investigatorAffiliation': 'Luzerner Kantonsspital'}}}}