Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT05421533
Status:
TERMINATED
Last Update Posted:
2024-12-03
First Post:
2022-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 705}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Concentration of resources on Phase 3 studies', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of characteristics of patients with AF, including reasons anticoagulation is not used', 'timeFrame': '24 Months', 'description': 'Information collected from physicians will provide the clinical reasons for treatment or nontreatment with OACs as assessed by the treating physicians'}, {'measure': 'Bleeding', 'timeFrame': '24 Months', 'description': 'Number of all bleeding events in patients with AF who are treated with guideline recommended doses of oral anticoagulants for stroke prevention versus those who are not'}, {'measure': 'Stroke and systemic embolic events', 'timeFrame': '24 Months', 'description': 'Number of stroke and systemic embolic events in patients with AF who are treated with guideline recommended doses of oral anticoagulants for stroke prevention versus those who are not'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Observational Study', 'Real-World Evidence', 'Atrial Fibrillation', 'Stroke', 'Bleeding', 'Systemic Thromboembolic Event'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The GARDENIA registry will collect real-world clinical data on the anticoagulant strategies in patients with AF at elevated risk of stroke but also elevated risk of bleeding.', 'detailedDescription': "The GARDENIA registry will collect real-world clinical data on the utilization of oral anticoagulants in patients with atrial fibrillation (AF) at elevated risk of stroke. Patients with AF who meet 1 or more of the following criteria will be recruited: advanced age, renal dysfunction, the need for concomitant antiplatelet use, or otherwise judged to be at a higher risk of bleeding. Patients with these criteria are frequently not treated with currently approved oral anticoagulants or they are 'undertreated' based on the use of non-recommended doses of anticoagulants. These patients will be described with regards to baseline demographics and characteristics with particular attention focused on physician and patient factors that may play a role in the under use of guideline-recommended anticoagulation therapy for stroke prevention in patients with AF. Patients in the registry will also be followed to determine the rates of discontinuation/switching of their anticoagulation therapy, incidence of major adverse cardiovascular events and clinically relevant outcome events related to the selection of their anticoagulation therapy. The collected real-world data will be used to inform future studies of patients with AF at elevated risk of stroke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AF at elevated risk of stroke with advanced age, renal dysfunction, the need for concomitant antiplatelet use, or otherwise judged to be at increased risk of bleeding. Initial feasibility cohort will recruit approximately 1500 patients with AF who are not currently treated with oral anticoagulants at baseline before opening the study to patients with AF regardless of antithrombotic strategy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent from the patient, or legally authorized representative, must be obtained before any assessment is performed\n* Patients with diagnosed AF or atrial flutter(documented on an electrocardiogram or monitor recording)\n* CHA2DS2-VASc score ≥2 excluding female as a factor\n* Judged by the investigator to be at increased risk of bleeding because of at least 1 of the following:\n\n * Age ≥70on the day of informed consent\n * Reduced renal function (creatinine clearance \\<30mL/min by Cockcroft-Gault)\n * Chronic use of NSAIDs or antiplatelet agents\n * Any other condition associated with increased risk such as a prior history of major or clinically relevant nonmajor bleeding, increased fall risk, or frailty\n* Patients who are not treated with oral anticoagulants (only applies to the initial feasibility cohort)\n\nExclusion Criteria:\n\n* Mechanical heart valve or valve disease that is expected to require valve replacement intervention (surgical or invasive) during the course of the registry study\n* AF due to a reversible cause (eg, cardiac surgery, pulmonary embolism, untreated hyperthyroidism, ethanol use)\n* Clinical unstable or active endocarditis or endovascular infection\n* Patients with a medical condition other than AF for which chronic use of an oral anticoagulant is indicated\n* History of left atrial appendage closure or removal\n* Life expectancy \\<1 year at the time of enrollment as assessed by the investigator\n* Any medical or psychiatric condition which in the judgment of the Investigator may preclude patients from complying with study requirements for the duration of the study'}, 'identificationModule': {'nctId': 'NCT05421533', 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