Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-01 @ 9:27 AM
Study NCT ID:
NCT02559232
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2015-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': 'At baseline visit', 'description': 'sociodemographic data'}, {'measure': 'Gender', 'timeFrame': 'At baseline visit', 'description': 'sociodemographic data'}, {'measure': 'Race', 'timeFrame': 'At baseline visit', 'description': 'sociodemographic data'}, {'measure': 'Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding', 'timeFrame': 'At baseline visit', 'description': 'sociodemographic data'}, {'measure': 'Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Concomitant treatments: therapy group of relevant active substances', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics; therapy group of relevant active substances: antiarrhythmics, Angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, dihydropyridine calcium channel blockers, diuretics, hypolipemiant drugs, oral anti-diabetics and human insulin, antiplatelet agents, nonsteroidal anti-inflammatory drugs, Proton-pump inhibitors, others: specify'}, {'measure': 'Risk of thromboembolic event based on the CHADS2 score', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke'}, {'measure': 'Risk of thromboembolic event based on the CHA2DS2-VASc score', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category'}, {'measure': 'Risk of bleeding based on the HAS-BLED score', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly'}], 'secondaryOutcomes': [{'measure': 'Adherence to treatment', 'timeFrame': 'At baseline visit', 'description': 'use of Haynes-Sackett test'}, {'measure': 'Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire', 'timeFrame': 'At baseline visit'}, {'measure': 'Compliance with the criteria in therapeutic positioning report UT/V4/23122013', 'timeFrame': 'At baseline visit', 'description': 'In some Spanish regions it is mandatory to accomplish the conditions of the national guideline UT/V4/23122013 regarding the use of direct oral anticoagulant. In that guideline the characteristics of patients candidates to direct oral anticoagulant are explained.'}, {'measure': 'Use of healthcare resources: Number of visits with primary care physician. Number of visits with specialist, Number of visits with nursing staff, Number of visits to A&E, Number of diagnostic tests in the period when the change was made, related to NVAF.', 'timeFrame': 'At baseline visit', 'description': 'Healthcare resources'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke', 'Prevention and Control', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients at risk of stroke or systemic embolism on anticoagulant therapy, who have changed their therapeutic regimen according to their doctor's decision, due to any clinical situation and based on routine clinical practice, and who at the time of enrolment in the study have been receiving treatment with a DOAC for at least three months", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres.\n* Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent).\n* Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care.\n* Patients who have given their informed consent in writing.\n\nExclusion Criteria:\n\n* Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent.\n* Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires.\n* Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant .'}, 'identificationModule': {'nctId': 'NCT02559232', 'acronym': 'BRONCE-AP', 'briefTitle': 'An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers', 'orgStudyIdInfo': {'id': '17961'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DOAC treated patients', 'description': 'Patients diagnosed with Non-Valvular Atrial Fibrillation at risk of stroke or systemic embolism treated in primary care centres with DOAC.', 'interventionNames': ['Drug: Direct Oral Anticoagulant (DOAC)']}], 'interventions': [{'name': 'Direct Oral Anticoagulant (DOAC)', 'type': 'DRUG', 'description': 'Treatment pattern following the summary of product characteristics', 'armGroupLabels': ['DOAC treated patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Spain'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}