Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-02-24 @ 5:07 AM
Study NCT ID:
NCT02072668
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Rivaroxaban in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kataga@uthsc.edu', 'phone': '901.448.3181', 'title': 'Dr. Kenneth Ataga', 'organization': 'University of Tennessee Center for the Heath Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data collected from date of informed consent to end of study visit, approximately 3 months', 'description': 'The safety analysis population includes all participants exposed to any study intervention evaluated in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'pain crisis treated at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ankle laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tick bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea, nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tinea versicolor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevate liver enzymes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cough, fever, body aches, congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain in lower extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pelvic pressure with urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'right flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'painful crisis with bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '-115.5', 'upperLimit': '197.2'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '-84.5', 'upperLimit': '105.8'}]}]}], 'analyses': [{'pValue': '0.6281', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported only for those participants who completed both interventions.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-4.47', 'upperLimit': '2.28'}, {'value': '-0.54', 'groupId': 'OG001', 'lowerLimit': '-1.69', 'upperLimit': '0.62'}]}]}], 'analyses': [{'pValue': '0.7973', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay performed for IL-6 using a commercially available enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported only for those participants who completed both interventions.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.14', 'groupId': 'OG000', 'lowerLimit': '-4.13', 'upperLimit': '1.85'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '-3.48', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '0.4442', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Interleukin-2 (IL-2) was measured using Luminex MAP technology at the UNC core facility', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analyzed for the 13 participants completing both interventions but results for 6 participants in each group fell outside the standard curve and could not be extrapolated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '-41.83', 'upperLimit': '43.72'}, {'value': '-4.08', 'groupId': 'OG001', 'lowerLimit': '-38.36', 'upperLimit': '30.19'}]}]}], 'analyses': [{'pValue': '0.2545', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Interleukin-8 (IL-8) was measured using Luminex MAP technology at the UNC core facility', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analyzed for the 13 participants completing both interventions but results for 4 participants in the rivaroxaban group and 5 participants in the placebo group fell outside the standard curve and could not be extrapolated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'timeFrame': 'Baseline, 4 weeks', 'description': 'high sensitivity C-reactive protein (hsCRP) was measured using Luminex MAP technology at the UNC core facility.', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation MPO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'timeFrame': 'Baseline, 4 weeks', 'description': 'myeloperoxidase (MPO) was measured using Luminex MAP technology at the UNC core facility.', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation TNF-a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'timeFrame': 'Baseline, 4 weeks', 'description': 'tumor necrosis factor alpha (TNF-a) was measured using Luminex MAP technology at the UNC core facility.', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation sPLA2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'timeFrame': 'Baseline, 4 weeks', 'description': 'secretory phospholipase A2 (sPLA2) was measured using Luminex MAP technology at the UNC core facility', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Marker of Endothelial Cell (EC) Activation sICAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban, Then Placebo', 'description': 'Participants first received Rivaroxaban 20 mg tablet once daily for 4 weeks. After a washout period of 2 weeks, they then received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks.\n\nRivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks'}, {'id': 'OG001', 'title': 'Placebo, Then Rivaroxaban', 'description': 'Participants first received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks. After a washout period of 2 weeks, they then received Rivaroxaban 20 mg tablet once daily for 4 weeks.\n\nRivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks'}], 'timeFrame': 'Baseline, 4 weeks', 'description': 'levels of soluble intracellular adhesion molecule (sICAM) were measured using a commercially available ELISA', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker evaluations were limited to VCAM-1 and IL-6 as those were thought more likely to reflect endothelial cell activation based on experience in recent studies.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in TH1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '2.47'}, {'value': '-0.51', 'groupId': 'OG001', 'lowerLimit': '-2.72', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.4374', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to half before hyperemia (TH1)', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to each treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in TM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.97', 'groupId': 'OG000', 'lowerLimit': '-5.71', 'upperLimit': '3.77'}, {'value': '-2.01', 'groupId': 'OG001', 'lowerLimit': '-6.82', 'upperLimit': '2.81'}]}]}], 'analyses': [{'pValue': '0.3470', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to max (TM)', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to each treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in AH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000', 'lowerLimit': '-373', 'upperLimit': '628'}, {'value': '-1189', 'groupId': 'OG001', 'lowerLimit': '-2597', 'upperLimit': '218'}]}]}], 'analyses': [{'pValue': '0.0755', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: hyperemia area (AH)', 'unitOfMeasure': 'perfusion units*seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to each treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Ratio From Baseline to Week 4 in AH/AO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '0.57'}, {'value': '-0.81', 'groupId': 'OG001', 'lowerLimit': '-2.05', 'upperLimit': '0.42'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variables measured: hyperemia area (AH) and occlusion area (AO)', 'unitOfMeasure': 'ratio of AH to AO', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to each treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in PF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'groupId': 'OG000', 'lowerLimit': '-9.08', 'upperLimit': '15.36'}, {'value': '-12.62', 'groupId': 'OG001', 'lowerLimit': '-26.63', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '0.0708', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: peak flow (PF)', 'unitOfMeasure': 'perfusion units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to each treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in RF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '-1.47', 'upperLimit': '2.05'}, {'value': '-0.62', 'groupId': 'OG001', 'lowerLimit': '-2.96', 'upperLimit': '1.73'}]}]}], 'analyses': [{'pValue': '0.4501', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: rest flow (RF)', 'unitOfMeasure': 'perfusion units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to each treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in TAT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.44', 'groupId': 'OG000', 'lowerLimit': '-69.4', 'upperLimit': '0.53'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '-3.77', 'upperLimit': '4.47'}]}]}], 'analyses': [{'pValue': '0.0767', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay for thrombin antithrombin (TAT) complexes performed using commercially available enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'ug/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported only for those participants who completed both interventions.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in D-Dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban', 'description': 'Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '-471', 'groupId': 'OG000', 'lowerLimit': '-1654', 'upperLimit': '712'}, {'value': '-1035', 'groupId': 'OG001', 'lowerLimit': '-3880', 'upperLimit': '1810'}]}]}], 'analyses': [{'pValue': '0.7250', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Student t-test followed by ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay for D--dimer is performed using commercially available enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported only for those participants who completed both interventions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivaroxaban, Then Placebo', 'description': 'Participants first received Rivaroxaban 20 mg tablet once daily for 4 weeks. After a washout period of 2 weeks, they then received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks.\n\nRivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks'}, {'id': 'FG001', 'title': 'Placebo, Then Rivaroxaban', 'description': 'Participants first received placebo (matching Rivaroxaban 20 mg tablet) once daily for 4 weeks. After a washout period of 2 weeks, they then received Rivaroxaban 20 mg tablet once daily for 4 weeks.\n\nRivaroxaban: 20 mg tablet by mouth daily for 4 weeks Placebo: Matching placebo tablet by mouth daily for 4 weeks'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '15 subjects signed informed consent and were successfully screened. One subject withdrew during Baseline and prior to the first intervention and data from this individual are included in the baseline characteristics. One subject entered the second intervention period but was lost to follow up before receiving the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Participants', 'description': 'Participants who had a screening visit'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.00', 'spread': '10.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.22', 'spread': '11.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '169.40', 'spread': '10.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only measured on the participants who received study medication'}, {'title': 'White Blood Cell (WBC) count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8.49', 'spread': '2.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Genotype - Hemoglobin SS (HbSS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Platelet count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '370.07', 'spread': '169.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prothrombin Time (PT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.54', 'spread': '0.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'A test that measures how quickly blood clots', 'unitOfMeasure': 'sec', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only measured on the participants who received study medication'}, {'title': 'International Normalized Ratio (INR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The ratio of a patient's prothrombin time to a normal (control) sample", 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only measured on the participants who received study medication'}, {'title': 'Partial Thromboplastin Time (PTT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.16', 'spread': '2.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measures the time it takes for a blood clot to form', 'unitOfMeasure': 'sec', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only measured on the participants who received study medication'}], 'populationDescription': 'All participants who had a screening visit'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-20', 'size': 1662194, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-05T09:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2014-02-24', 'resultsFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2014-02-25', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-09', 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay performed for IL-6 using a commercially available enzyme-linked immunosorbent assay (ELISA).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Interleukin-2 (IL-2) was measured using Luminex MAP technology at the UNC core facility'}, {'measure': 'Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Interleukin-8 (IL-8) was measured using Luminex MAP technology at the UNC core facility'}, {'measure': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation hsCRP', 'timeFrame': 'Baseline, 4 weeks', 'description': 'high sensitivity C-reactive protein (hsCRP) was measured using Luminex MAP technology at the UNC core facility.'}, {'measure': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation MPO', 'timeFrame': 'Baseline, 4 weeks', 'description': 'myeloperoxidase (MPO) was measured using Luminex MAP technology at the UNC core facility.'}, {'measure': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation TNF-a', 'timeFrame': 'Baseline, 4 weeks', 'description': 'tumor necrosis factor alpha (TNF-a) was measured using Luminex MAP technology at the UNC core facility.'}, {'measure': 'Change From Baseline to Week 4 in Plasma Marker of Inflammation sPLA2', 'timeFrame': 'Baseline, 4 weeks', 'description': 'secretory phospholipase A2 (sPLA2) was measured using Luminex MAP technology at the UNC core facility'}, {'measure': 'Change From Baseline to Week 4 in Marker of Endothelial Cell (EC) Activation sICAM', 'timeFrame': 'Baseline, 4 weeks', 'description': 'levels of soluble intracellular adhesion molecule (sICAM) were measured using a commercially available ELISA'}, {'measure': 'Change From Baseline to Week 4 in TH1', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to half before hyperemia (TH1)'}, {'measure': 'Change From Baseline to Week 4 in TM', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to max (TM)'}, {'measure': 'Change From Baseline to Week 4 in AH', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: hyperemia area (AH)'}, {'measure': 'Change in Ratio From Baseline to Week 4 in AH/AO', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variables measured: hyperemia area (AH) and occlusion area (AO)'}, {'measure': 'Change From Baseline to Week 4 in PF', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: peak flow (PF)'}, {'measure': 'Change From Baseline to Week 4 in RF', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: rest flow (RF)'}, {'measure': 'Change From Baseline to Week 4 in TAT', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay for thrombin antithrombin (TAT) complexes performed using commercially available enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Change From Baseline to Week 4 in D-Dimer', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Assay for D--dimer is performed using commercially available enzyme-linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sickle cell anemia', 'sickle cell disease', 'rivaroxaban', 'direct Xa inhibition', 'coagulation', 'anticoagulation'], 'conditions': ['Sickle Cell Anemia', 'Sickle Cell-Beta0-Thalassemia']}, 'referencesModule': {'references': [{'pmid': '33660875', 'type': 'DERIVED', 'citation': 'Ataga KI, Elsherif L, Wichlan D, Wogu AF, Matsui N, Pawlinski R, Cai J, Key NS. A pilot study of the effect of rivaroxaban in sickle cell anemia. Transfusion. 2021 Jun;61(6):1694-1698. doi: 10.1111/trf.16343. Epub 2021 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce inflammation, coagulation and endothelial cell activation, and improve microvascular blood flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test this hypothesis, this study will evaluate the effects of rivaroxaban on:\n\n* plasma markers of inflammation;\n* plasma markers of endothelial activation;\n* plasma markers of thrombin generation; and\n* microvascular blood flow assessed using laser Doppler velocimetry (LDV) of post-occlusive reactive hyperemia (PORH).\n\nIn a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks each, separated by a 2-week washout phase.', 'detailedDescription': 'The study will consist of a Screening Phase, two Treatment Phases, a Wash-Out Phase, and a Follow-up Phase. The Screening Phase will occur within 28 days of randomization and will include informed consent, a physical examination, and complete medical history to include determination of sickle cell genotype and current medications. Clinical laboratory tests to be performed include: a Complete Blood Count (CBC) with differential and reticulocyte count; Prothrombin time(PT) / activated partial thromboplastin time (aPTT); and serum chemistries (BUN, creatinine, total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and LDH). A chest x-ray and MRI/MRA of the brain will also be done at Screening to rule out underlying disease.\n\nIf the patient is found through the screening process to be eligible, the 1st Treatment Phase begins. Baseline safety assessments and measurement of biomarkers are completed, then the subject is randomized to receive rivaroxaban or placebo. After 4 weeks of treatment, there is a 2-Week Wash-Out Phase. After the Wash-Out Phase, another set of baseline studies are performed and the 2nd Treatment Phase begins. For this Phase of the study, the subject "crosses over" to receive whatever treatment - rivaroxaban or placebo - that they did not receive in the 1st Treatment Phase. After taking the assigned study drug for 4 weeks, the 2nd Treatment Phase ends. The subject returns 2 weeks after the last dose of study treatment for the Follow-Up Phase, consisting of a single end-of-study visit during which safety assessments are repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years of age; sickle cell anemia (HbSS) or sickle-beta0 (HbSβ0) thalassemia;\n* serum creatinine ≤ 1.0 mg/dL men) or 1.2 mg/dL (women);\n* ALT \\</= 2 times upper limits of normal;\n* platelet count ≥ 50,000 cu/mm;\n* normal baseline PT/international normalized ratio (INR) and aPTT;\n* be in the non-crisis, "steady state" with no severe pain episodes during the preceding 4 weeks;\n* ability to understand the requirements of the study and be willing to give informed consent;\n* women of childbearing age must be practicing an adequate method of contraception;\n* and if on hydroxyurea, be on a stable dose for at least 3 months prior to enrollment.\n\nExclusion Criteria:\n\n* hypersensitivity to any component of rivaroxaban;\n* history of major GI bleeding or bleeding diathesis;\n* baseline Hb \\< 5.5 gm/dL;\n* history of clinically overt stroke;\n* brain magnetic resonance imaging with angiography (MRI/MRA) scan with evidence of Moya Moya;\n* pregnant or breastfeeding;\n* active liver disease or ALT \\> 3 times upper limit of normal;\n* on chronic anticoagulant, non-steroidal anti-inflammatory (NSAID) or statin therapy;\n* history of metastatic cancer;\n* current alcohol abuse;\n* on a chronic transfusion program or any blood transfusion in the 3 months prior to enrollment;\n* ingested any investigational drugs within the past 4 weeks;\n* use of CYP3A4/P-glycoprotein inducers such as carbamazepine, phenytoin, rifampin, and St John\'s wort;\n* use of CYP3A4/P- glycoprotein inhibitors such as ketoconazole, indinavir/ritonavir, itraconazole, lopinavir/ritonavir, ritonavir, and conivaptan.'}, 'identificationModule': {'nctId': 'NCT02072668', 'briefTitle': 'The Effect of Rivaroxaban in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'The Effect of Factor Xa Inhibition, With Rivaroxaban, on the Pathology of Sickle Cell Disease', 'orgStudyIdInfo': {'id': '12-2607'}, 'secondaryIdInfos': [{'id': 'U01HL117659-01', 'link': 'https://reporter.nih.gov/quickSearch/U01HL117659-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Rivaroxaban for 4 wks, Placebo for 4 wks', 'description': 'Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.', 'interventionNames': ['Drug: rivaroxaban', 'Drug: placebo']}, {'type': 'OTHER', 'label': 'Placebo for 4 wks, rivaroxaban for 4 wks', 'description': 'Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.', 'interventionNames': ['Drug: rivaroxaban', 'Drug: placebo']}], 'interventions': [{'name': 'rivaroxaban', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': 'Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.', 'armGroupLabels': ['Placebo for 4 wks, rivaroxaban for 4 wks', 'Rivaroxaban for 4 wks, Placebo for 4 wks']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.', 'armGroupLabels': ['Placebo for 4 wks, rivaroxaban for 4 wks', 'Rivaroxaban for 4 wks, Placebo for 4 wks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Kenneth I Ataga, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Nigel Key, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}