Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT02227550
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy
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': 'C008208', 'term': 'acarboxyprothrombin'}, {'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D010644', 'term': 'Phenprocoumon'}, {'id': 'C017673', 'term': 'fluindione'}, {'id': 'C522181', 'term': 'apixaban'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 676}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death and serious cardiovascular events', 'timeFrame': 'appr. 4 months', 'description': 'A composite of all-cause death, stroke (ischemic stroke, subarachnoid haemorrhage and haemorrhagic stroke), and major bleeding events, def.as BARC 2 or higher'}], 'secondaryOutcomes': [{'measure': 'any bleeding event', 'timeFrame': 'appr. 4 months', 'description': 'number'}, {'measure': 'major bleeding events acc. to the ISTH and TIMI definitions', 'timeFrame': 'appr. 4 months', 'description': 'number'}, {'measure': 'strokes, other systemic embolic events and all-cause death', 'timeFrame': 'appr. 4 month', 'description': 'number'}, {'measure': 'time from randomisation to ablation', 'timeFrame': 'appr. 4 months', 'description': 'number of days'}, {'measure': 'nights spent in hospital after ablation', 'timeFrame': 'appr. 4 months', 'description': 'number'}, {'measure': 'health-care related cost calculation', 'timeFrame': 'appr. 4 months'}, {'measure': 'hospitalizations for cardiovascular reasons', 'timeFrame': 'appr. 4 months', 'description': 'number'}, {'measure': 'Treatment duration prior to ablation and total time on oral anticoagulation', 'timeFrame': 'appr. 4 months', 'description': 'number of days'}, {'measure': 'patients with clinically indicated TEE', 'timeFrame': 'appr. 4 months', 'description': 'number of patients'}, {'measure': 'ACT during ablation', 'timeFrame': 'during ablation', 'description': 'Active clotting measurements'}, {'measure': 'recurrent Atrial Fibrillation (AF)', 'timeFrame': 'appr. 4 months', 'description': 'time to recurrent AF'}, {'measure': 'rhythm status at the end of follow-up', 'timeFrame': 'end of follow-up', 'description': 'rythm status documented by 24 hour Holter ECG'}, {'measure': 'vascular access complications leading to prolongation of in-hospital stay or specific therapy', 'timeFrame': 'appr. 4 months', 'description': 'number of events'}, {'measure': 'Quality-of-life changes', 'timeFrame': 'baseline to 3 month follow-up', 'description': 'questionaire'}, {'measure': 'cognitive function change', 'timeFrame': 'baseline to 3 month follow-up', 'description': 'questionaire'}, {'measure': 'clinically "silent" MRI-detected brain lesions', 'timeFrame': 'within 48 hours after ablation procedures', 'description': 'prevalence (MRI-substudy)'}, {'measure': 'Impact of ablation-associated clinically overt strokes or MRI-detected bus clincally "silent" acute brain lesions on cognitive function after ablation', 'timeFrame': 'appr. 4 months', 'description': 'MRI-substudy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrilal fibrillation', 'anticoagulation', 'prevention of peri-procedural complication', 'catheter ablation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '28130378', 'type': 'BACKGROUND', 'citation': 'Di Biase L, Callans D, Haeusler KG, Hindricks G, Al-Khalidi H, Mont L, Cosedis Nielsen J, Piccini JP, Schotten U, Kirchhof P. Rationale and design of AXAFA-AFNET 5: an investigator-initiated, randomized, open, blinded outcome assessment, multi-centre trial to comparing continuous apixaban to vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation. Europace. 2017 Jan;19(1):132-138. doi: 10.1093/europace/euw368.'}, {'pmid': '37897713', 'type': 'DERIVED', 'citation': 'Haeusler KG, Eichner FA, Heuschmann PU, Fiebach JB, Engelhorn T, Callans D, De Potter T, Debruyne P, Scherr D, Hindricks G, Al-Khalidi HR, Mont L, Kim WY, Piccini JP, Schotten U, Themistoclakis S, Di Biase L, Kirchhof P. Detection of brain lesions after catheter ablation depends on imaging criteria: insights from AXAFA-AFNET 5 trial. Europace. 2023 Dec 6;25(12):euad323. doi: 10.1093/europace/euad323.'}, {'pmid': '35135308', 'type': 'DERIVED', 'citation': 'Haeusler KG, Eichner FA, Heuschmann PU, Fiebach JB, Engelhorn T, Blank B, Callans D, Elvan A, Grimaldi M, Hansen J, Hindricks G, Al-Khalidi HR, Mont L, Nielsen JC, Piccini JP, Schotten U, Themistoclakis S, Vijgen J, Di Biase L, Kirchhof P. MRI-Detected Brain Lesions and Cognitive Function in Patients With Atrial Fibrillation Undergoing Left Atrial Catheter Ablation in the Randomized AXAFA-AFNET 5 Trial. Circulation. 2022 Mar 22;145(12):906-915. doi: 10.1161/CIRCULATIONAHA.121.056320. Epub 2022 Feb 9.'}, {'pmid': '32725107', 'type': 'DERIVED', 'citation': 'Zink MD, Chua W, Zeemering S, di Biase L, Antoni BL, David C, Hindricks G, Haeusler KG, Al-Khalidi HR, Piccini JP, Mont L, Nielsen JC, Escobar LA, de Bono J, Van Gelder IC, de Potter T, Scherr D, Themistoclakis S, Todd D, Kirchhof P, Schotten U. Predictors of recurrence of atrial fibrillation within the first 3 months after ablation. Europace. 2020 Sep 1;22(9):1337-1344. doi: 10.1093/europace/euaa132.'}]}, 'descriptionModule': {'briefSummary': 'Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications.\n\nThe AXAFA trial will compare peri-ablational treatment with apixaban to peri-ablational treatment wit VKA in a randomized trial of patients undergoing catheter ablation of atrial fibrillation (AF).', 'detailedDescription': 'AXAFA is an open-label trial designed to evaluate the safety and efficacy of two types of anticoagulant therapy, VKA therapy and therapy with the direct factor Xa inhibitor apixaban, in patients undergoing scheduled catheter ablation for AF. All patients will undergo the ablation procedure after pre-treatment with an anticoagulant (either apixaban in the "Xa group" or a vitamin K antagonist in the "VKA group").\n\nPatients can undergo catheter ablation within the trial after at least 30 days of continuous effective anticoagulation. Ablation can be performed earlier when or timely after exclusion of atrial thrombi have been excluded by a clinically indicated by transthoracic echocardioggram (TEE). After TEE continuous effective anticoagulation must be ensured until the end of the trial.\n\nIn the MRI-substudy will be explored wether novel oral anticoagulants (NOAC) have the potential to reduce clinically silent brain lesions after catheter ablation of AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nI1. Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation\n\nI2. Clinical indication to undergo catheter ablation on continuous anticoagulant therapy\n\nI3. Presence of at least one of the CHADS2 stroke risk factors\n\n* Stroke or TIA\n* age ≥ 75 years,\n* hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure \\> 145/90 mm Hg,\n* diabetes mellitus,\n* symptomatic heart failure (NYHA ≥ II).\n\nI4. Age ≥ 18 years\n\nI5. Provision of signed informed consent\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\nE1. Any disease that limits life expectancy to less than 1 year\n\nE2. Participation in another clinical trial, either within the past two months or still ongoing\n\nE3. Previous participation in AXAFA\n\nE4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception (oral contraception or intra-uterine device) or sterile women can be randomised.\n\nE5. Breastfeeding women\n\nE6. Drug abuse or clinically manifest alcohol abuse\n\nE7. Any stroke within 14 days before randomisation\n\nE8. Coadministration with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) or strong dual inducers of CYP3A4 and P-gp (Appendix VIII).\n\nExclusion criteria related to a cardiac condition\n\nE9. Valvular AF (as defined by the focussed update of the ESC guidelines on AF, i.e. severe mitral valve stenosis, mechanical heart valve). Furthermore, patients who underwent mitral valve repair are not eligible for AXAFA.\n\nE10. Any previous ablation or surgical therapy for AF\n\nE11. Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation\n\nE12. Clinical need for "triple therapy" (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)\n\nE13. Other contraindications for use of VKA or apixaban\n\nE14. Documented atrial thrombi less than 3 months prior to randomisation.\n\nExclusion criteria based on laboratory abnormalities\n\nE15. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) \\< 15 ml/min'}, 'identificationModule': {'nctId': 'NCT02227550', 'acronym': 'AXAFA', 'briefTitle': 'Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Atrial Fibrillation Network'}, 'officialTitle': 'An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial to Determine the Optimal Anticoagulation Therapy for Patients Untergoing Catheter Ablation of Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'AFNET 5 AXAFA'}, 'secondaryIdInfos': [{'id': '2014-002442-45', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apixaban', 'description': 'Xa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin K antagonist', 'description': 'VKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine', 'interventionNames': ['Drug: Vitamin K antagonist']}], 'interventions': [{'name': 'Vitamin K antagonist', 'type': 'DRUG', 'otherNames': ['warfarin', 'phenprocoumon', 'acecoumaril', 'fluindione'], 'description': 'any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin', 'armGroupLabels': ['Vitamin K antagonist']}, {'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['BMS-562247'], 'description': 'factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose) dose reduction Apixaban 2,5 mg twice daily in patients who fulfill tow of the following criteria at the time of randomisation: chronic kidney disease (serum creatine \\>= 1.5 mg/dl (133mM), \\<= 60 kg body weight or age \\>= 80 years.', 'armGroupLabels': ['Apixaban']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsyvlania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Cariovascular Research Insititute', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Different', 'country': 'Austria', 'facility': '4 Sites'}, {'city': 'Different', 'country': 'Belgium', 'facility': '5 Sites'}, {'city': 'Different', 'country': 'Denmark', 'facility': '5 Sites'}, {'city': 'Different', 'country': 'Germany', 'facility': '13 Sites'}, {'city': 'Different', 'country': 'Italy', 'facility': '4 Sites'}, {'city': 'Different', 'country': 'Netherlands', 'facility': '6 Sites'}, {'city': 'Different', 'country': 'Spain', 'facility': '3 Sites'}, {'city': 'Different', 'country': 'United Kingdom', 'facility': '4 Sites'}], 'overallOfficials': [{'name': 'Paulus Kirchhof, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham Centre for Cardiovascular Scienes, UK and University Hospital Muenster, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atrial Fibrillation Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}