Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-06 @ 1:42 AM
Study NCT ID:
NCT02339818
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2015-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportions of HCPs using Eliquis and patients treated with Eliquis with knowledge of the important identified risk of bleeding associated with Eliquis treatment measured through web-based survey results', 'timeFrame': 'At the time of completion of a survey (approximately 6 to 12 months)'}], 'secondaryOutcomes': [{'measure': 'The proportions of HCPs using Eliquis and patients treated with Eliquis who have received the Risk minimization (RM) tools measured through web-based survey results', 'timeFrame': 'At the time of completion of a survey (approximately 6 to 12 months)'}, {'measure': 'The proportions of HCPs using Eliquis and patients treated with Eliquis who have utilized the RM tools, and the extent of tool usage measured through web-based survey results', 'timeFrame': 'At the time of completion of a survey (approximately 6 to 12 months)'}, {'measure': 'The levels and distributions of behavior questionnaire results for HCPs and patients measured through web-based survey results', 'timeFrame': 'At the time of completion of a survey (approximately 6 to 12 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke, Systemic Embolism, VTEt and VTEp']}, 'referencesModule': {'references': [{'pmid': '33660230', 'type': 'DERIVED', 'citation': 'Mayall S, Kahlon R, Al-Dakkak I, Shen SW. Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Pharmaceut Med. 2021 Mar;35(2):123-135. doi: 10.1007/s40290-021-00380-1. Epub 2021 Mar 4.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide and Patient Alert Card in terms knowledge of the important identified risk of bleeding associated with Eliquis treatment communicated by the RM tools.', 'detailedDescription': 'Observational Model, Other- This is a non-interventional, cross-sectional study in the EEA involving representative samples of HCPs who treat patients with Eliquis, as well as patients treated with Eliquis. This study will be facilitated via web-based surveys used to evaluate the effectiveness of the Eliquis Prescribe Guide and Patient Alert Card as risk management tools.\n\nEnrollment: 384 Health Care Professions (HCPs) and 192 Patients\n\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults (VTEt)\n\nPrevention of VTE in adult patients knee replacement surgery (VTEp)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HCPs will be considered for participation in the study if they prescribe/use Eliquis for any approved indications, including the following subgroups as appropriate for each country:\n\n* Cardiologists (including allied specialties, e.g. angiologists, electrophysiologists)\n* Non-cardiology specialists (e.g. internal medicine/hospital general medicine physicians, geriatricians/care of the elderly physicians, neurologists, hematologists, orthopedic surgeons)\n* General practitioners/internal medicine\n* Other HCPs (e.g. nurses, pharmacists)\n* Patients taking Eliquis for all three currently approved indications', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* HCP must have been involved in the treatment of at least one patient with Eliquis for any approved indication\n* Patients must have taken Eliquis for any approved indication'}, 'identificationModule': {'nctId': 'NCT02339818', 'briefTitle': 'Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries', 'orgStudyIdInfo': {'id': 'CV185-365'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCPs', 'description': 'HCPs involved in using Eliquis (apixaban)'}, {'label': 'Patients', 'description': 'Patients taking Eliquis for any of the three currently approved indications'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}