Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-30 @ 5:02 PM
Study NCT ID:
NCT01660061
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2012-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2012-08-06', 'studyFirstSubmitQcDate': '2012-08-06', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between INR and CFX correlate >20%', 'timeFrame': '0, 1, 2, 3, 6 and 12 month'}], 'secondaryOutcomes': [{'measure': 'Arterial or venous thrombosis', 'timeFrame': '12 months', 'description': 'Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antiphospholipid syndrome', 'Antiphospholipid antibodies', 'Vitamin-K antagonists', 'International normalized ratio', 'Chromogenic factor X'], 'conditions': ['Antiphospholipid Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gefaesszentrum-frankfurt.de/forschung.php', 'label': 'Click here for more information about this study: Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome'}]}, 'descriptionModule': {'briefSummary': 'To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.', 'detailedDescription': 'Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary prevention after a first thrombotic complication are known to be at higher risk of recurrent thrombotic events despite INR values in the therapeutic range. It ist also known that antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin time and INR).\n\nThe primary objective of this study is to determine the prevalence of interfering antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring the INR using different thromboplastins and the CoaguChek system for INR self-assessment. Test results were compared to measurements of the phospholipid-independent chromogenic factor X.\n\nThe second objective of this study is to evaluate the incidence of recurrent thrombotic events during 1-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with antiphospholipid syndrome requiring long-term treatment with vitamin-K antagonists (N=40) Pateints without antiphospholipid antibodies treated with vitamin-K antagonists (N=100)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-90 years\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01660061', 'briefTitle': 'Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome', 'orgStudyIdInfo': {'id': 'EV 77/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'APS patients', 'description': 'Patients with antiphospholipid syndrome requiring long-term anticoagulant therapy with vitamin-K antagonists'}, {'label': 'Controls', 'description': 'Patients without antiphospholipid antibodies requiring anticoagulant therapy with vitamin-K antagonists'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Birgit Linnemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University Hospital, Division of Vascular Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv.-Doz. Dr. Birgit Linnemann', 'investigatorFullName': 'Birgit Linnemann', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}