Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT03413618
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2018-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D054070', 'term': 'Postthrombotic Syndrome'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D004145', 'term': 'Diosmin'}, {'id': 'D053828', 'term': 'Stockings, Compression'}], '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': 'D047309', 'term': 'Flavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D058128', 'term': 'Compression Bandages'}, {'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lobastov_kv@hotmail.com', 'phone': '+7-985-211-63-31', 'title': 'Dr. Kirill Lobastov', 'organization': 'Pirogov Russian National Research Medical University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Unsuspected high frequency of PTS in the Control group (standard treatment with rivaroxaban and compression stockings) led to early termination of enrollment (75% of planned sample size).'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Study Group', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 5, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 4, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dispesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clinically relevant non-major bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Minor bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Detection of the postthrombotic syndrome (PTS) was made according to the Villalta score (a combination of 5 subjective symptoms and 6 objective signs of chronic venous disease) ranged from 0 (no signs) to 33 scores (maximal severity). PTS defined as 5 and more scores; mild PTS as 5-9 scores; moderate PTS as 10-14 scores; severe PTS as 15 and more scores.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Recurrent Symptomatic or Asymptomatic DVT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic Pulmonary Embolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Value of Venous Clinical Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Venous Clinical Severity Score (VCSS) is a combination of subjective symptoms and objective signs of CVD aimed to assess the severity of disease and ranges from 0 (no signs and symptoms of CVD) to 30 (severe signs and symptoms of CVD)', 'unitOfMeasure': 'VCSS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '28.8', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20) is a venous specific questionnaire to assess the disease-specific quality of life (QoL). It contains 20 items of 1-5 scores, totally, from 20 (best QoL) to100 (worst QoL) scores.', 'unitOfMeasure': 'CIVIQ-20 scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Full Recanalization of the Popliteal Vein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Full recanalization of popliteal vein suggests the residual venous obstruction (RVO) less than 20%. The RVO was assessed by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without any compression multiplied by 100%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Extension of Residual Venous Obstruction by Marder Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb).', 'unitOfMeasure': 'Marder score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'any adverse events detected or suspected', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinically Relevant Non-major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minor Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'OG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': "any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'FG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Admitted to the hospital with the suspicion for DVT: 202; DVT verified: 158; Eligible DVT: 102; Rejected to participate: 12; Randomized: 90'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Rivaroxaban + Diosmin + Stocking', 'description': 'treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\nDiosmin: 600 mg q.d. for 12 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'BG001', 'title': 'Control: Rivaroxaban + Stockings Only', 'description': 'standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings\n\nRivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month\n\ncompression stockings: above knee stocking for 12 month'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.4', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time to randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of days from DVT verification to randomization', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Unprovoked DVT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'DVT without any identified clinical provocation (e.g. major surgery, trauma, immobilization, pregnancy and postpartum, estrogen-containing pills, long-travel, etc)', 'unitOfMeasure': 'Participants'}, {'title': 'Preexisting chronic venous disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Chronic venous disease (CVD) according to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) clinical class: C0 - no signs for CVD; C1 - telangiectasia and reticular veins; C2 - varicose veins; C3 - venous edema; C4 - skin pigmentation, induration, venous eczema of skin white atrophy; C5 - healed venous ulcer; C6 - active venous ulcer. Preexisting CVD suggests C2 and higher CEAP clinical class.', 'unitOfMeasure': 'Participants'}, {'title': 'Thrombus burden', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '11.6', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Extension of DVT assessed with duplex ultrasound by Marder score (see Appendix 1 to the Protocol): ranges from 0 (no thrombus) to 34 (occlusion of all veins in one limb).', 'unitOfMeasure': 'Marder score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-11', 'size': 443022, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-30T06:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Outcomes assessor does not involve in randomisation and treatment process, has no information about the patient's belonging to one of the study groups"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized open-labeled clinical trial with a masked outcomes assessor'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2018-01-18', 'resultsFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-14', 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score', 'timeFrame': '12 months', 'description': 'Detection of the postthrombotic syndrome (PTS) was made according to the Villalta score (a combination of 5 subjective symptoms and 6 objective signs of chronic venous disease) ranged from 0 (no signs) to 33 scores (maximal severity). PTS defined as 5 and more scores; mild PTS as 5-9 scores; moderate PTS as 10-14 scores; severe PTS as 15 and more scores.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Recurrent Symptomatic or Asymptomatic DVT', 'timeFrame': '12 months', 'description': 'detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound'}, {'measure': 'Number of Participants With Symptomatic Pulmonary Embolism', 'timeFrame': '12 months', 'description': 'detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram'}, {'measure': 'The Value of Venous Clinical Severity Score', 'timeFrame': '12 months', 'description': 'Venous Clinical Severity Score (VCSS) is a combination of subjective symptoms and objective signs of CVD aimed to assess the severity of disease and ranges from 0 (no signs and symptoms of CVD) to 30 (severe signs and symptoms of CVD)'}, {'measure': 'The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items', 'timeFrame': '12 months', 'description': 'Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20) is a venous specific questionnaire to assess the disease-specific quality of life (QoL). It contains 20 items of 1-5 scores, totally, from 20 (best QoL) to100 (worst QoL) scores.'}, {'measure': 'Number of Participants With Full Recanalization of the Popliteal Vein', 'timeFrame': '12 months', 'description': 'Full recanalization of popliteal vein suggests the residual venous obstruction (RVO) less than 20%. The RVO was assessed by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without any compression multiplied by 100%.'}, {'measure': 'Extension of Residual Venous Obstruction by Marder Score', 'timeFrame': '12 months', 'description': 'Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb).'}, {'measure': 'Adverse Events', 'timeFrame': '12 months', 'description': 'any adverse events detected or suspected'}, {'measure': 'Major Bleeding', 'timeFrame': '12 months', 'description': 'according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells'}, {'measure': 'Clinically Relevant Non-major Bleeding', 'timeFrame': '12 months', 'description': 'any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment'}, {'measure': 'Minor Bleeding', 'timeFrame': '12 months', 'description': "any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deep vein thrombosis', 'postthrombotic syndrome', 'anticoagulation', 'treatment', 'prevention'], 'conditions': ['Deep Vein Thrombosis', 'Postthrombotic Syndrome']}, 'referencesModule': {'references': [{'pmid': '33201130', 'type': 'RESULT', 'citation': 'Lobastov K, Sautina E, Alencheva E, Bargandzhiya A, Schastlivtsev I, Barinov V, Laberko L, Rodoman G, Boyarintsev V. Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled Trial. Ann Surg. 2021 Jul 1;274(1):63-69. doi: 10.1097/SLA.0000000000004556.'}]}, 'descriptionModule': {'briefSummary': 'The randomized clinical study aimed to assess the efficacy and safety of standard anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.', 'detailedDescription': 'Deep vein thrombosis is an acute inflammatory disease that affects vein wall and leads to the structural changes in the wall and valves reflected with chronic venous insufficiency that called postthrombotic syndrome (PTS).\n\nDiosmin as a flavonoid agent has properties to reduce leukocyte-endothelial interaction and inflammatory response, that could reduce the damage to venous wall and valves.\n\nThe hypothesis of the study is based on assumption that diosmin combined with standard anticoagulation can improve outcomes of femoro-popliteal DVT due to increase speed of veins recanalization, decrease of vein wall inflammation and finally decrease the incidence of PTS at 6 month and 1 year after index DVT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* The first episode of femoro-popliteal deep vein thrombosis (DVT)\n* Verification of DVT by duplex ultrasound\n* Informed consent signed\n\nExclusion Criteria:\n\n* Suspicion of pulmonary embolism (PE)\n* Verified PE\n* Bilateral DVT\n* Contraindications for rivaroxaban (in accordance with the official instructions)\n* Contraindications for diosmin (in accordance with the official instructions)\n* Active cancer\n* Verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins C, S, antithrombin 3)\n* Use of other anticoagulants for more than 7 days from the DVT verification\n* Impossibility of using compression stocking after 3 days from DVT verification\n* Performed surgical intervention on the superficial or deep veins of the lower extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior cava filter)\n* Continuous use of other drugs that affect the hemostasis system (except for acetylsalicylic acid in a dose of not more than 100 mg).\n* Low compliance'}, 'identificationModule': {'nctId': 'NCT03413618', 'acronym': 'RIDILOTT-DVT', 'briefTitle': 'Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Pirogov Russian National Research Medical University'}, 'officialTitle': 'The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis', 'orgStudyIdInfo': {'id': 'RIDILOTT-DVT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Rivaroxaban + Diosmin + Stockings', 'description': 'treatment of deep vein thrombosis with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin', 'interventionNames': ['Drug: Rivaroxaban', 'Drug: Diosmin', 'Other: compression stockings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Rivaroxaban + Stockings only', 'description': 'standard treatment of deep vein thrombosis with anticoagulation (rivaroxaban) and elastic compression stockings', 'interventionNames': ['Drug: Rivaroxaban', 'Other: compression stockings']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'otherNames': ['xarelto'], 'description': '15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month', 'armGroupLabels': ['Control: Rivaroxaban + Stockings only', 'Experimental: Rivaroxaban + Diosmin + Stockings']}, {'name': 'Diosmin', 'type': 'DRUG', 'otherNames': ['flebodia'], 'description': '600 mg q.d. for 12 month', 'armGroupLabels': ['Experimental: Rivaroxaban + Diosmin + Stockings']}, {'name': 'compression stockings', 'type': 'OTHER', 'description': 'above knee stocking for 12 month', 'armGroupLabels': ['Control: Rivaroxaban + Stockings only', 'Experimental: Rivaroxaban + Diosmin + Stockings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '121352', 'city': 'Moscow', 'country': 'Russia', 'facility': "Clinical Hospital no.1 of the President's Administration of Russian Federation", 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Ilya Schastlivtsev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pirogov Russian National Research Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}