Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-04-21 @ 5:04 PM
Study NCT ID:
NCT02544932
Status:
UNKNOWN
Last Update Posted:
2015-09-09
First Post:
2015-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pleotropic Effect of New Oral Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], '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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D014859', 'term': 'Warfarin'}], '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'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-07', 'studyFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2015-09-07', 'lastUpdatePostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes in reactive hyperemia index (RHI)', 'timeFrame': '12months'}], 'secondaryOutcomes': [{'measure': 'right and left maximum IMT of the common carotid artery (CCA)', 'timeFrame': '24months'}, {'measure': 'right and left mean IMT of the common carotid artery (CCA)', 'timeFrame': '24months'}, {'measure': 'adverse events', 'timeFrame': '24months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anticoagulant', 'atherosclerosis', 'endothelium'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '27558002', 'type': 'DERIVED', 'citation': 'Kim JB, Joung HJ, Lee JM, Woo JS, Kim WS, Kim KS, Lee KH, Kim W. Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial. Trials. 2016 Aug 24;17(1):422. doi: 10.1186/s13063-016-1541-8.'}]}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.', 'detailedDescription': 'The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CHA2DS2-VASc score above 2\n\nExclusion Criteria:\n\n* severe peripheral arterial disease (greater than a Fontaine IIb category)\n* grade 4 or higher cerebral infarction on the Modified Rankin Scale\n* proven coronary artery disease by coronary angiogram\n* severe hepatic or renal dysfunction\n* uncontrolled congestive heart failure\n* uncontrolled hypertension or diabetes mellitus\n* hematologic disorders\n* allergy or hypersensitivity to the investigational drugs\n* pregnant or lactating women or women wishing to become pregnant'}, 'identificationModule': {'nctId': 'NCT02544932', 'briefTitle': 'Pleotropic Effect of New Oral Anticoagulants', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'PREFER-AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dabigatran 110mg or 150mg', 'description': 'After once enrolled, subjects will be randomized to dabigatran group. (110mg or 150mg twice a day)', 'interventionNames': ['Drug: dabigatran']}, {'type': 'EXPERIMENTAL', 'label': 'ribaroxaban 20mg', 'description': 'After once enrolled, subjects will be randomized to ribaroxaban group. (20mg once daily)', 'interventionNames': ['Drug: ribaroxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'warfarin', 'description': 'After once enrolled, subjects will be randomized to warfarin group. (controlled by INR 2-3)', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'dabigatran', 'type': 'DRUG', 'otherNames': ['pradaxa'], 'description': 'After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months', 'armGroupLabels': ['dabigatran 110mg or 150mg']}, {'name': 'ribaroxaban', 'type': 'DRUG', 'otherNames': ['xarelto'], 'description': 'After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.', 'armGroupLabels': ['ribaroxaban 20mg']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.', 'armGroupLabels': ['warfarin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-702', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Weon Kim, MD, PhD', 'role': 'CONTACT', 'email': 'mylovekw@hanmail.net', 'phone': '82-2-958-8170'}, {'name': 'Jin-Bae Kim, MD, PhD', 'role': 'CONTACT', 'email': 'jinbbai@khu.ac.kr', 'phone': '82-2-958-8167'}], 'overallOfficials': [{'name': 'Weon Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Weon Kim', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}