Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-25 @ 6:10 PM
Study NCT ID:
NCT02331602
Status:
UNKNOWN
Last Update Posted:
2015-08-06
First Post:
2014-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'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': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-04', 'studyFirstSubmitDate': '2014-01-05', 'studyFirstSubmitQcDate': '2015-01-03', 'lastUpdatePostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism)and frequency of 12-month major bleeding (defined as ISTH criteria)', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, and interleukin-18) between at baseline and 12 months later in each treatment group', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'change over time of above inflammatory markers during 12 months follow-up period (at baseline, 1 month, 3 months, 6 months, and 12 months later) in each treatment group', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'anticoagulation', 'inflammation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.', 'detailedDescription': 'Previous study showed that administration of rivaroxaban reduced expression of proinflammatory mediators in apolipoprotein E-deficient mice. However, it is unknown whether the anti-inflammatory markers are decreased in patients with atrial fibrillation receiving novel oral anticoagulants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-valvular atrial fibrillation\n* a CHADS2-VASc score of 1 or more\n\nExclusion Criteria:\n\n* contraindication for rivaroxaban or dabigatran\n* stroke or systemic embolism, acute coronary syndromes or peripheral artery disease within 6 months before enrollment\n* acute heart failure\n* severe chronic renal failure (creatinine clearance \\< 30mL/min.)\n* receiving dual antiplatelet therapy\n* patients with a body weight of 50kg or less\n* uncontrolled hypertension\n* active malignancy, collagen disease, or infectious disease\n* patients undergoing surgery within 6 months before enrollment\n* patients who are planned to undergoing catheter ablation for atrial fibrillation\n* patients who are not allowed to participate in the trial by judgement of the treating physician'}, 'identificationModule': {'nctId': 'NCT02331602', 'acronym': 'RIVAL-AF', 'briefTitle': 'Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran', 'organization': {'class': 'OTHER', 'fullName': 'Yokohama City University Medical Center'}, 'officialTitle': 'Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study-', 'orgStudyIdInfo': {'id': 'Kimura5656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rivaroxaban', 'description': 'Patients are assigned to receive rivaroxaban 15mg once daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.', 'interventionNames': ['Drug: Rivaroxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dabigatran', 'description': 'Patients are assigned to receive dabigatran 150mg twice daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.', 'interventionNames': ['Drug: Dabigatran']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': 'Patients are assigned to receive rivaroxaban 15mg once daily for 12 months. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.', 'armGroupLabels': ['rivaroxaban']}, {'name': 'Dabigatran', 'type': 'DRUG', 'otherNames': ['Pradaxa'], 'description': 'Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.', 'armGroupLabels': ['dabigatran']}]}, 'contactsLocationsModule': {'locations': [{'zip': '258-0003', 'city': 'Ashigaura', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Izumi Kobayashi, MD', 'role': 'CONTACT', 'email': 'eno_r@hotmail.com', 'phone': '81-465-83-0351'}, {'name': 'Izumi Kobayashi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ashigara Kami Hospital'}, {'zip': '253-0042', 'city': 'Chigasaki', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Atsushi Wada, MD', 'role': 'CONTACT', 'email': 'Chigasaki-circ@hotmail.co.jp', 'phone': '81-467-52-1111'}, {'name': 'Atsushi Wada, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chigasaki Municipal Hospital', 'geoPoint': {'lat': 35.33638, 'lon': 139.40434}}, {'zip': '251-8550', 'city': 'Fujisawa', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hideo Himeno, MD', 'role': 'CONTACT', 'email': 'hdohimeno@jcom.home.ne.jp', 'phone': '81-466-25-3111'}, {'name': 'Hideo Himeno, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fujisawa City Hospital', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'zip': '252-0802', 'city': 'Fujisawa', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takahiro Takei, MD', 'role': 'CONTACT', 'email': 't_takei@fj-shounandai.or.jp', 'phone': '81-466-44-1451'}, {'name': 'Takahiro Takei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fujisawa Shounandai Hospital', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'zip': '257-0017', 'city': 'Hadano', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Reimin Sawada, MD', 'role': 'CONTACT', 'email': 'rsawada@live.jp', 'phone': '81-463-81-3721'}, {'name': 'Reimin Sawada, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadano Red Cross Hospital', 'geoPoint': {'lat': 35.37111, 'lon': 139.22361}}, {'zip': '252-0392', 'city': 'Sagamihara', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yukiko Morita, MD', 'role': 'CONTACT', 'email': 'y-morita@sagamihara-hosp.gr.jp', 'phone': '81-42-742-8311'}, {'name': 'Yukiko Morita, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Hospital Organization Sagamihara National Hospital', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '226-0027', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takeshi Takamura, MD', 'role': 'CONTACT', 'email': 'tkmrt@yokohama-cu.ac.jp', 'phone': '81-45-981-1201'}, {'name': 'Takeshi Takamura, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nagatsuta kousei general hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazuo Kimura, MD', 'role': 'CONTACT', 'email': 'c-kimura@urahp.yokohama-cu.ac.jp', 'phone': '81-45-261-5656'}, {'name': 'Kazuo Kimura, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kengo Tsukahara, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '234-8503', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tsutomu Endo, MD', 'role': 'CONTACT', 'email': 'endotu@nanbu.saiseikai.or.jp', 'phone': '81-45-832-1111'}, {'name': 'Tsutomu Endo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saiseikai Yokohama City Southern Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '236-0051', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazuki Fukui, MD', 'role': 'CONTACT', 'email': 'Fukui@kanagawa-junko.jp', 'phone': '81-45-701-9581'}, {'name': 'Kazuki Fukui, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kanagawa Cardiovascular and Respiratory Disease Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '240-8585', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shunichi Kobayashi, MD', 'role': 'CONTACT', 'email': 'shunichi_kobayashi@sempos.or.jp', 'phone': '81-45-331-1251'}, {'name': 'Shunichi Kobayashi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Yokohama Seamen's Insurance Hospital", 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '245-0006', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Makoto Shimizu, MD', 'role': 'CONTACT', 'email': 'makotoshimizuyaizu@gmail.com', 'phone': '81-45-813-0221'}, {'name': 'Makoto Shimizu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'International Goodwill Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Teruyasu Sugano, MD', 'role': 'CONTACT', 'email': 't_sugano@yokohama-cu.ac.jp', 'phone': '81-45-787-2800'}, {'name': 'Teruyasu Sugano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yokohama City University Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '240-0195', 'city': 'Yokosuka', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Jun Okuda, MD', 'role': 'CONTACT', 'email': 'jokudajun@yahoo.co.jp', 'phone': '81-46-856-3136'}, {'name': 'Jun Okuda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yokosuka City hospital', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'zip': '413-0012', 'city': 'Atami', 'state': 'Shizuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tomohiko Shigemasa, MD', 'role': 'CONTACT', 'email': 'tshig@iuhw.ac.jp', 'phone': '81-557-81-9171'}, {'name': 'Tomohiko Shigemasa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'International University of Health and Welfare Atami Hospital', 'geoPoint': {'lat': 35.08834, 'lon': 139.05325}}, {'zip': '143-8527', 'city': 'Ohta', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yasuyuki Mochida, MD', 'role': 'CONTACT', 'email': 'y-mochi@u01.gate01.com', 'phone': '81-3-3775-3111'}, {'name': 'Yasuyuki Mochida, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Omori Red Cross Hospital'}], 'centralContacts': [{'name': 'Kengo Tsukahara, MD', 'role': 'CONTACT', 'email': 'k-tsuka@urahp.yokohama-cu.ac.jp', 'phone': '81-45-261-5656'}], 'overallOfficials': [{'name': 'Kazuo Kimura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yokohama City University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yokohama City University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yokohama City University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Division of Cardiology', 'investigatorFullName': 'Kiyoshi Hibi', 'investigatorAffiliation': 'Yokohama City University Medical Center'}}}}