Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT02646267
Status:
UNKNOWN
Last Update Posted:
2016-01-05
First Post:
2016-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients
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': 'D000069604', 'term': 'Dabigatran'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'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': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2016-01-03', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ischaemic stroke', 'timeFrame': '2 years', 'description': 'ischaemic stroke was defined as a blockage in an artery that supplies blood to the brain , resulting in a deficiency in blood flow and focal neurological deficit lasting \\>24 hours.'}, {'measure': 'major haemorrhage', 'timeFrame': '2 years', 'description': 'Major haemorrhage was defined as intracranial hemorrhage, gastrointestinal bleeding, bleeding requiring hospitalization and surgical intervention, a reduction of hemoglobin by≥2 g/dL, requiring red blood cells transfusion ≥2 units.'}], 'secondaryOutcomes': [{'measure': 'minor bleeding', 'timeFrame': '2 years'}, {'measure': 'myocardial infarction', 'timeFrame': '2 years'}, {'measure': 'pulmonary embolism', 'timeFrame': '2 years'}, {'measure': 'cardiovascular death', 'timeFrame': '2 years'}, {'measure': 'all-cause mortality', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Dabigatran', 'Warfarin', 'Anticoagulation', 'Elderly'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '23200268', 'type': 'BACKGROUND', 'citation': 'Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of atrial fibrillation\n2. Echocardiography confirmed a non-valvular heart disease\n3. Age≥60 years\n\nExclusion Criteria:\n\n1. Unable to cooperate with doctors\n2. CHA2DS2-VASc\\<2\n3. Life expectancy of less than 1 year\n4. Rheumatic heart disease or dilated cardiomyopathy\n5. History of artificial valve replacement surgery\n6. Infectious endocarditis\n7. Stroke or transient ischemic attack(TIA) within the last 6 months\n8. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding\n9. Previous intolerance/allergy to warfarin or dabigatran etexilate\n10. Blood pressure greater than 180/110 mmHg\n11. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times\n12. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min\n13. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons'}, 'identificationModule': {'nctId': 'NCT02646267', 'briefTitle': 'The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'The Efficacy and Safety of Dabigatran Etexilate and Different Intensity Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'SEL102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'standard intensity warfarin group', 'description': 'standard intensity warfarin group， target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0)', 'interventionNames': ['Drug: standard intensity warfarin']}, {'type': 'EXPERIMENTAL', 'label': 'low intensity warfarin group', 'description': 'low intensity warfarin group， target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2)', 'interventionNames': ['Drug: low intensity warfarin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dabigatran etexilate group', 'description': '110mg dabigatran etexilate was administrated twice a day', 'interventionNames': ['Drug: dabigatran etexilate']}], 'interventions': [{'name': 'standard intensity warfarin', 'type': 'DRUG', 'description': 'target international normalised ratio(INR) was 2.1-3.0', 'armGroupLabels': ['standard intensity warfarin group']}, {'name': 'low intensity warfarin', 'type': 'DRUG', 'description': 'target international normalised ratio(INR) was 1.7-2.2', 'armGroupLabels': ['low intensity warfarin group']}, {'name': 'dabigatran etexilate', 'type': 'DRUG', 'description': '110mg, twice a day, oral', 'armGroupLabels': ['dabigatran etexilate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Wu Jun, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}