Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT06142604
Status:
WITHDRAWN
Last Update Posted:
2024-08-29
First Post:
2023-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005424', 'term': 'Flecainide'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Feasibility', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'through study completion, an average of six months', 'description': 'Minimum recruitment rate of at least 1.5 patients per site per month'}, {'measure': 'Follow-up completion rate', 'timeFrame': 'through study completion, an average of six months', 'description': 'Completion rate of at least 90%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flecainide'], 'conditions': ['Atrial Fibrillation', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.', 'detailedDescription': 'FLIP-AF is a prospective, randomized, open-label trial of single dose flecainide versus no flecainide in patients with perioperative atrial fibrillation after noncardiac surgery. The primary objective is to determine whether it is feasible to conduct a large randomized controlled trial assessing the efficacy and safety of single dose flecainide in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Noncardiac surgery in the last 30 days requiring an overnight hospital admission;\n* Presence of AF (i.e., atrial fibrillation and/or flutter) with a ventricular heart rate of ≥ 100 beats per minute at any time within 12 hours prior to randomization;\n* In AF at the time of randomization; AND,\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* History of AF without normal sinus rhythm documented within 90 days prior to randomization;\n* Hemodynamic instability;\n* Have any one of the following contraindications to flecainide:\n\n 1. known left ventricular ejection fraction ≤ 40%;\n 2. myocardial infarction within the last 30 days;\n 3. QRS interval \\>140ms;\n 4. allergy to flecainide;\n 5. severe uncorrected hypokalemia (\\<2.5 mEq/L) or hyperkalemia (\\>6.5 mEq/L) at the time of randomization;\n 6. severe acute liver dysfunction or history of advanced cirrhosis;\n 7. severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,\n 8. second or third degree atrioventricular block within the last 30 days, in the absence of a pacemaker device;\n* Unable to take oral medication;\n* Previously enrolled in the trial.'}, 'identificationModule': {'nctId': 'NCT06142604', 'acronym': 'FLIP-AF', 'briefTitle': 'Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-FLIPAF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flecainide', 'description': 'Participants randomized to the flecainide arm will be prescribed a single 300mg dose of oral flecainide, to be given as soon as possible after study randomization. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization.', 'interventionNames': ['Drug: Flecainide']}, {'type': 'NO_INTERVENTION', 'label': 'No flecainide', 'description': 'Participants randomized to the no flecainide arm will not be prescribed flecainide. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization.'}], 'interventions': [{'name': 'Flecainide', 'type': 'DRUG', 'description': 'Single 300mg dose of oral flecainide', 'armGroupLabels': ['Flecainide']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}