Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 6:39 PM
Study NCT ID:
NCT05491460
Status:
UNKNOWN
Last Update Posted:
2022-08-08
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'C552171', 'term': 'edoxaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS', 'timeFrame': 'up to 6 months', 'description': 'Assess the accuracy and specificity of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients True positive and true negative rate of the point of care test (POCT) by comparison with the results obtained by bioanalytical quantification'}], 'secondaryOutcomes': [{'measure': 'Comparison of qualitative POCT with quantitative LC-MS/MS', 'timeFrame': 'up to 6 months', 'description': 'Comparison of qualitative POCT with quantitative LC-MS/MS Investigator readings of POCT test results as compared to LC-MS/MS'}, {'measure': 'Questionnaire on handling and usability', 'timeFrame': 'up to 6 months', 'description': 'Specific questions to be answered using Lickert scale by personal performing the test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anticoagulant', 'direct oral anticoagulant', 'apixaban', 'edoxaban', 'rivaroxaban', 'dabigatran', 'coagulation', 'point of care method'], 'conditions': ['Anticoagulant Therapy']}, 'referencesModule': {'references': [{'pmid': '30134449', 'type': 'BACKGROUND', 'citation': 'Harenberg J, Schreiner R, Hetjens S, Weiss C. Detecting Anti-IIa and Anti-Xa Direct Oral Anticoagulant (DOAC) Agents in Urine using a DOAC Dipstick. Semin Thromb Hemost. 2019 Apr;45(3):275-284. doi: 10.1055/s-0038-1668098. Epub 2018 Aug 22.'}]}, 'descriptionModule': {'briefSummary': "DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time \\[PT\\] and activated partial thromboplastin time \\[aPTT\\]) from plasma samples show a high variation. Special coagulation tests like hemoclot for dabigatran and chromogenic substrate assays for Rivaroxaban, Apixaban, and Edoxaban are time-consuming and can be performed only in specialized laboratories. In specific medical situations like in patients such as emergency procedures, stroke (before starting thrombolytic therapy), trauma, general surgery or other invasive procedures, it may be necessary for medical decision making to know the presence or absence of a DOAC in patient's body fluid. Until now there is no rapid, specific and sensitive coagulation test available in the market.", 'detailedDescription': 'This prospective, open-label, controlled, not randomized trial in healthy volunteers to investigate comparatively the pharmacokinetics of the direct oral anticoagulants in plasma and in urine with LC-MS/MS and in urine by DOAC Dipstick.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fully signed and dated written informed consent\n\n * Age \\>18 years\n * healthy\n\nExclusion Criteria:\n\n* Patients not able to provide urine samples.\n\n * Patients not able to understand the informed consent or severe mentally disabled.\n * Patients in the end-stage of a severe disease.'}, 'identificationModule': {'nctId': 'NCT05491460', 'acronym': 'PHAPOCU', 'briefTitle': 'Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Doasense GmbH'}, 'officialTitle': 'Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'PhaKiDo-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Apixaban', 'description': 'Volunteers receive one oral dose of 5mg Apxiaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.\n\nBiological and clinical safety parameters are measured.', 'interventionNames': ['Drug: Apixaban 5 MG Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dabigatran', 'description': 'Volunteers receive one oral dose of 150mg Dabigatran followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.\n\nBiological and clinical safety parameters are measured.', 'interventionNames': ['Drug: Dabigatran 150 MG Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Edoxaban', 'description': 'Volunteers receive one oral dose of 60mg Edoxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.\n\nBiological and clinical safety parameters are measured.', 'interventionNames': ['Drug: Edoxaban 60Mg Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rivaroxaban', 'description': 'Volunteers receive one oral dose of 20mg Rivaroxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.\n\nBiological and clinical safety parameters are measured.', 'interventionNames': ['Drug: Rivaroxaban 20 MG Tab']}], 'interventions': [{'name': 'Apixaban 5 MG Tab', 'type': 'DRUG', 'otherNames': ['Edoxaban, Dabigatran, rivaroxaban'], 'description': 'oral intake', 'armGroupLabels': ['Apixaban']}, {'name': 'Dabigatran 150 MG Tab', 'type': 'DRUG', 'otherNames': ['Apixaban, Edoxaban, Rivaroxaban'], 'description': 'oral intake', 'armGroupLabels': ['Dabigatran']}, {'name': 'Edoxaban 60Mg Tab', 'type': 'DRUG', 'otherNames': ['Apixaban, Dabigatran, Rivaroxaban'], 'description': 'oral intake', 'armGroupLabels': ['Edoxaban']}, {'name': 'Rivaroxaban 20 MG Tab', 'type': 'DRUG', 'otherNames': ['Apixaban, Edoxaban, Dabigatran'], 'description': 'oral intake', 'armGroupLabels': ['Rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Clincial Research Serivces', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Armin Schultz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Doasense GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Job Harenberg', 'investigatorAffiliation': 'Heidelberg University'}}}}