Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-08 @ 10:08 PM
Study NCT ID:
NCT02610933
Status:
COMPLETED
Last Update Posted:
2019-01-28
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061205', 'term': 'Vascular Calcification'}], 'ancestors': [{'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D024482', 'term': 'Vitamin K 2'}], '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': 'D014812', 'term': 'Vitamin K'}, {'id': 'D009285', 'term': 'Naphthoquinones'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010836', 'term': 'Phytol'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absolute and relative change in coronary artery calcification score', 'timeFrame': '18 months', 'description': 'score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)'}, {'measure': 'absolute and relative change in thoracic aortic calcification score', 'timeFrame': '18 months', 'description': 'score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)'}, {'measure': 'absolute and relative change in pulse wave velocity', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'absolute and relative change in aortic valve calcification score', 'timeFrame': '18 months', 'description': 'score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)'}, {'measure': 'absolute and relative change in mitral valve calcification score', 'timeFrame': '18 months', 'description': 'score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)'}, {'measure': 'mortality from any cause', 'timeFrame': '18 months'}, {'measure': 'myocardial infarction, acute coronary syndrome, symptom-driven coronary revascularization and death from cardiovascular cause', 'timeFrame': '18 months'}, {'measure': 'Stroke, defined as sudden onset of focal neurological deficit consistent with the territory of a major cerebral artery and categorised as ischaemic, haemorrhagic, or unspecified.', 'timeFrame': '18 months'}, {'measure': 'Systemic embolism, defined as an acute vascular occlusion of a limb or organ documented by imaging, surgery, or autopsy.', 'timeFrame': '18 months'}, {'measure': 'Major bleeding, defined as a requirement for transfusion of two or more units of blood or a decrease in haemoglobin of 2 g/dL or more.', 'timeFrame': '18 months'}, {'measure': 'Life-threatening bleeding, defined as fatal bleeding, symptomatic intracranial bleeding, a decrease in haemoglobin of 5 g/dL or more, or a requirement for transfusion of four or more units of blood, inotropic agents, or surgery.', 'timeFrame': '18 months'}]}, 'conditionsModule': {'keywords': ['vascular calcification', 'hemodialysis', 'rivaroxaban', 'vitamin K2'], 'conditions': ['Vascular Calcification']}, 'referencesModule': {'references': [{'pmid': '38189593', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation, who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a vitamin K antagonist.\n\nThe first question is whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification. The second question is whether addition of vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular calcification.', 'detailedDescription': 'The present study targets dialysis patients with non-valvular atrial fibrillation requiring treatment with vitamin K antagonists. It addresses the question whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification (VC). The second research question is whether addition of vitamin K2 to rivaroxaban can further beneficially affect the progression of VC. Two non-invasive methods are used to evaluate the impact of interventions on the progression of VC: i.e. coronary artery calcification (CAC) and pulse wave velocity (PWV) measurements. The detection of CAC is predictive for the presence of obstructive coronary artery disease and future coronary events. VC and stiffening of the central elastic-type arteries are independent predictors of cardiovascular morbidity and mortality in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* end stage renal failure treated with chronic hemodialysis\n* atrial fibrillation\n* CHA2DS2-VASc Score ≥ 2\n* ability to provide informed consent\n\nExclusion Criteria:\n\n* known intestinal malabsorption or inability to take oral medication\n* inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort)\n* investigator's assessment that the subject's life expectancy is less than 1 year\n* prosthetic mechanical heart valve\n* contraindication for anticoagulation\n* liver dysfunction Child-Pugh grade B-C\n* pregnancy, breastfeeding, inadequate contraception\n* incompliance with medication and scheduled investigations"}, 'identificationModule': {'nctId': 'NCT02610933', 'briefTitle': 'Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouw Hospital'}, 'officialTitle': 'The Effect of Replacement of Vitamin K Antagonist by Rivaroxaban With or Without Vitamin K2 Supplementation on Vascular Calcifications in Chronic Hemodialysis Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2014/065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Vitamin K antagonist', 'description': 'Vitamin K antagonist treatment targeting an international normalized ratio of 2 to 3 for 18 months'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rivaroxaban', 'description': 'Rivaroxaban 10 mg tablet by mouth once daily for 18 months', 'interventionNames': ['Drug: rivaroxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rivaroxaban and vitamin K2', 'description': 'Rivaroxaban 10 mg tablet by mouth once daily and MK-7 2000 microgram tablet by mouth thrice weekly for 18 months', 'interventionNames': ['Drug: rivaroxaban', 'Dietary Supplement: Vitamin K2']}], 'interventions': [{'name': 'rivaroxaban', 'type': 'DRUG', 'description': 'replacement of vitamin K antagonist by rivaroxaban', 'armGroupLabels': ['rivaroxaban', 'rivaroxaban and vitamin K2']}, {'name': 'Vitamin K2', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['MK-7'], 'description': 'Vitamin K2 supplementation', 'armGroupLabels': ['rivaroxaban and vitamin K2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Hospital', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}], 'overallOfficials': [{'name': 'Rogier Caluwé, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrology Department OLV Hospital Aalst Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onze Lieve Vrouw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Rogier Caluwé, MD', 'investigatorFullName': 'Rogier Caluwe', 'investigatorAffiliation': 'Onze Lieve Vrouw Hospital'}}}}