Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-20 @ 5:31 AM
Study NCT ID:
NCT02470767
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres
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': 792}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of demographic characteristics: age, gender and race', 'timeFrame': 'At baseline visit', 'description': 'sociodemographic data'}, {'measure': 'Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Concomitant treatments: relevant active substances', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Risk of thromboembolic event based on the CHADS2 score', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Risk of thromboembolic event based on the CHA2DS2-VASc score', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}, {'measure': 'Risk of bleeding based on the HAS-BLED score', 'timeFrame': 'At baseline visit', 'description': 'clinical characteristics'}], 'secondaryOutcomes': [{'measure': 'Adherence to treatment', 'timeFrame': 'At baseline visit', 'description': 'use of Haynes-Sackett test'}, {'measure': 'Satisfaction of treatment', 'timeFrame': 'At baseline visit', 'description': 'use of ACTS questionnaire'}, {'measure': 'Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)', 'timeFrame': 'At baseline visit', 'description': 'use IPT guideline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke', 'Prevention and Control', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on anticoagulant therapy who have changed their therapeutic regimen, due to any clinical situation, based on the doctor's routine clinical practice 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 NVAF with a risk of stroke or systemic embolism treated in primary care centres.\n* Patients on regular treatment with anticoagulants who have changed their ther-apeutic regimen due to any clinical situation and have been on treatment with a DOAC for at least three months before being recruited (date of signing the in-formed consent).\n* Patients whose DOAC has been indicated by the primary care physician.\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 NVAF with a DOAC.'}, 'identificationModule': {'nctId': 'NCT02470767', 'acronym': 'SILVER-AP', 'briefTitle': 'An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres', 'orgStudyIdInfo': {'id': '17964'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DOAC treated patients', 'description': 'Patients diagnosed with Non-Valvular Atrial Fribilation 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'}}}}