Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-01 @ 7:09 AM
Study NCT ID:
NCT02433366
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2015-03-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'phoneExt': '+1', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse events (AE) were not reported in this trial report but in case a physician or patient mentioned an AE during the interview, the interviewer together with the physician or patient was to complete an AE form which was forwarded to pharmacovigilance unit of BI.', 'eventGroups': [{'id': 'EG000', 'title': 'Physicians', 'description': 'Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients', 'description': 'AF patients on treatment with Pradaxa®.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physicians', 'description': 'Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).'}, {'id': 'OG001', 'title': 'Patients', 'description': 'AF patients on treatment with Pradaxa®.'}], 'classes': [{'title': 'A', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'C', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'D', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.\n\nThis Outcome measure is applicable only for the Physicians group.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)'}, {'type': 'PRIMARY', 'title': "Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physicians', 'description': 'Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).'}, {'id': 'OG001', 'title': 'Patients', 'description': 'AF patients on treatment with Pradaxa®.'}], 'classes': [{'title': 'A', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'C', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'D', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'E', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'F', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'AF patients on treatment with Pradaxa®.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Physicians', 'description': 'Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).'}, {'id': 'FG001', 'title': 'Patients', 'description': 'AF patients on treatment with Pradaxa®.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '802'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '802'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This is a cross-sectional survey. Pradaxa® prescribing healthcare professionals and Pradaxa® treated patients were randomly selected and interviewed (face-to-face).\n\n411 healthcare professionals and 802 patients with atrial fibrillation were enrolled and entered the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'BG000'}, {'value': '802', 'groupId': 'BG001'}, {'value': '1213', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Physicians', 'description': 'Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).'}, {'id': 'BG001', 'title': 'Patients', 'description': 'AF patients on treatment with Pradaxa®.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<75 years', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Information about physicians age is not available', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}, {'title': '≥ 75 years', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Information about physicians age is not available', 'groupId': 'BG000'}, {'value': '322', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Information about physicians gender is not available', 'groupId': 'BG000'}, {'value': '370', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Information about physicians gender is not available', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF) and AF patients who were currently receiving treatment with Pradaxa® entered this non-interventional survey'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2015-03-25', 'resultsFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-28', 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)", 'timeFrame': 'Day 1', 'description': 'The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.\n\nThis Outcome measure is applicable only for the Physicians group.'}, {'measure': "Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)", 'timeFrame': 'Day 1', 'description': 'The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.', 'detailedDescription': 'Purpose:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Physicians prescribing dabigatran for patients with atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pradaxa® prescribers (cardiologists and primary care physicians)\n* Patients with atrial fibrillation treated with Pradaxa®\n\nExclusion criteria:\n\nAs defined in Summary of Product Characteristics for patients treated with Pradaxa®'}, 'identificationModule': {'nctId': 'NCT02433366', 'briefTitle': 'Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF', 'orgStudyIdInfo': {'id': '1160.149'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients'}, {'label': 'Physicians'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dobrich', 'country': 'Bulgaria', 'facility': 'Boehringer Ingelheim Investigational Site 81', 'geoPoint': {'lat': 43.56491, 'lon': 27.83138}}, {'city': 'Gabrovo', 'country': 'Bulgaria', 'facility': 'Boehringer Ingelheim Investigational Site 84', 'geoPoint': {'lat': 42.87419, 'lon': 25.31823}}, {'city': 'Montana', 'country': 'Bulgaria', 'facility': 'Boehringer Ingelheim Investigational Site 79', 'geoPoint': {'lat': 43.41285, 'lon': 23.22174}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Boehringer Ingelheim Investigational Site 85', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Shumen', 'country': 'Bulgaria', 'facility': 'Boehringer Ingelheim Investigational Site 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