Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-03-27 @ 3:55 AM
Study NCT ID:
NCT02325466
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.rosenson@mssm.edu', 'phone': '212-241-9101', 'title': 'Dr. Robert S. Rosenson', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'description': 'data collected for participants who return for any subsequent visits', 'eventGroups': [{'id': 'EG000', 'title': 'Aspirin/Ticagrelor Placebo', 'description': 'aspirin 81 mg daily and ticagrelor placebo twice daily\n\ncrossover order was never unblinded to PI and study team', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aspirin/Ticagrelor', 'description': 'aspirin 81 mg daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Aspirin Placebo/Ticagrelor', 'description': 'aspirin placebo daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 1, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'seriousEvents': [{'term': 'GI Bleeding', 'notes': 'prolonged hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Low Shear Blood Viscosity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin/Ticagrelor Placebo', 'description': 'aspirin 81 mg daily and ticagrelor placebo twice daily crossover order was never unblinded to PI and study team'}, {'id': 'OG001', 'title': 'Aspirin/Ticagrelor', 'description': 'aspirin 81 mg daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'OG002', 'title': 'Aspirin Placebo/Ticagrelor', 'description': 'aspirin placebo daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}], 'classes': [{'categories': [{'measurements': [{'value': '1.045', 'spread': '1.525', 'groupId': 'OG000'}, {'value': '-1.793', 'spread': '1.835', 'groupId': 'OG001'}, {'value': '-1.759', 'spread': '1.298', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 16', 'description': 'Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline', 'unitOfMeasure': '5 s^-1 cPs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data collected and included for any participants who return for any of their visits.'}, {'type': 'PRIMARY', 'title': 'Mean Change in High Shear Blood Viscosity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin/Ticagrelor Placebo', 'description': 'aspirin 81 mg daily and ticagrelor placebo twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'OG001', 'title': 'Aspirin/Ticagrelor', 'description': 'aspirin 81 mg daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'OG002', 'title': 'Aspirin Placebo/Ticagrelor', 'description': 'aspirin placebo daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}], 'classes': [{'categories': [{'measurements': [{'value': '0.165', 'spread': '0.318', 'groupId': 'OG000'}, {'value': '-0.228', 'spread': '0.469', 'groupId': 'OG001'}, {'value': '-0.231', 'spread': '0.360', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 16', 'description': 'Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity at week 16 to baseline', 'unitOfMeasure': '300 s^-1 cPs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data collected and included for any participants who return for any of their visits.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Peripheral Arterial Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin/Ticagrelor Placebo', 'description': 'aspirin 81 mg daily and ticagrelor placebo twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'OG001', 'title': 'Aspirin/Ticagrelor', 'description': 'aspirin 81 mg daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'OG002', 'title': 'Aspirin Placebo/Ticagrelor', 'description': 'aspirin placebo daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}], 'classes': [{'title': 'ABI right side', 'categories': [{'measurements': [{'value': '0.038', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.019', 'groupId': 'OG001'}, {'value': '0.095', 'spread': '0.051', 'groupId': 'OG002'}]}]}, {'title': 'ABI left side', 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '0.075', 'spread': '0.029', 'groupId': 'OG002'}]}]}, {'title': 'TBI right side', 'categories': [{'measurements': [{'value': '0.044', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.011', 'spread': '0.008', 'groupId': 'OG002'}]}]}, {'title': 'TBI left side', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.016', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.036', 'spread': '0.028', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 16', 'description': 'Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index (ABI) and toe brachial index (TBI) at week 16 compared to baseline.\n\nABI and TBI are taken in order to determine the existence and severity of peripheral arterial disease.\n\nABI - The normal range for the ankle-brachial index is between 0.90 and 1.30. ABI \\<0.90 is abnormal: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. The lower the index, the higher the chances of leg pain while exercising or limb-threatening low blood flow.\n\nTBI ≥ 0.7 is normal, TBI \\< 0.7 is abnormal.', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data collected for participants who return for their visits.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Microvascular Blood Flow Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin/Ticagrelor Placebo', 'description': 'aspirin 81 mg daily and ticagrelor placebo twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'OG001', 'title': 'Aspirin/Ticagrelor', 'description': 'aspirin 81 mg daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'OG002', 'title': 'Aspirin Placebo/Ticagrelor', 'description': 'aspirin placebo daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}], 'classes': [{'title': 'Right side', 'categories': [{'measurements': [{'value': '-4.10', 'spread': '13.30', 'groupId': 'OG000'}, {'value': '13.64', 'spread': '7.34', 'groupId': 'OG001'}, {'value': '-5.23', 'spread': '7.76', 'groupId': 'OG002'}]}]}, {'title': 'Left side', 'categories': [{'measurements': [{'value': '-5.60', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '24.76', 'spread': '8.36', 'groupId': 'OG001'}, {'value': '-4.29', 'spread': '7.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 16', 'description': 'Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index and toe pressures composite score at week 16 from baseline. Composite score obtained by adding all the measurements and averaged. The score was tested by the Laser Doppler Flowmetry (LDF). Minimum score is 0 which mean no blood flow detected and there is no maximum value of the score, and higher score mean better blood flow.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data collected for participants who return for their visits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aspirin/Ticagrelor Placebo', 'description': 'aspirin 81 mg daily and ticagrelor placebo twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'FG001', 'title': 'Aspirin/Ticagrelor', 'description': 'aspirin 81 mg daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}, {'id': 'FG002', 'title': 'Aspirin Placebo/Ticagrelor', 'description': 'aspirin placebo daily and ticagrelor 90 mg twice daily\n\ncrossover order was never unblinded to PI and study team'}], 'periods': [{'title': 'Period 1 Timeframe - Baseline to Week 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'urgent vascularization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Period 2 - Timeframe Week 4 to Week 10', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'urgent vascularization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '3rd Crossover - Week 10 to Week 16', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'urgent vascularization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment from April 2015 to April 2018. Study participants were recruited from the outpatient cardiology practice and the Cardiac Catheterization database at the Mount Sinai Hospital, New York, NY, USA.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Two crossovers with all participants experiencing all 3 arms'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent of cells', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fibrinogen', 'classes': [{'categories': [{'measurements': [{'value': '351', 'spread': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting glucose', 'classes': [{'categories': [{'measurements': [{'value': '124', 'spread': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '7.20', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood viscosity 300 s^-1', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Blood viscosity is a measure of the resistance of blood to flow. Blood viscosity measured at a shear rate of 300 s\\^-1', 'unitOfMeasure': 'centipoises (cPs)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood viscosity 5 s^-1', 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Blood viscosity measured at a shear rate of 5 s\\^-1', 'unitOfMeasure': 'cPs', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-19', 'size': 786847, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-06T14:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2014-12-19', 'resultsFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2014-12-19', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-18', 'studyFirstPostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Low Shear Blood Viscosity', 'timeFrame': 'baseline, week 16', 'description': 'Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline'}, {'measure': 'Mean Change in High Shear Blood Viscosity', 'timeFrame': 'baseline and week 16', 'description': 'Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity at week 16 to baseline'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Peripheral Arterial Blood Flow', 'timeFrame': 'baseline and week 16', 'description': 'Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index (ABI) and toe brachial index (TBI) at week 16 compared to baseline.\n\nABI and TBI are taken in order to determine the existence and severity of peripheral arterial disease.\n\nABI - The normal range for the ankle-brachial index is between 0.90 and 1.30. ABI \\<0.90 is abnormal: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. The lower the index, the higher the chances of leg pain while exercising or limb-threatening low blood flow.\n\nTBI ≥ 0.7 is normal, TBI \\< 0.7 is abnormal.'}, {'measure': 'Mean Change in Microvascular Blood Flow Composite Score', 'timeFrame': 'baseline and week 16', 'description': 'Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index and toe pressures composite score at week 16 from baseline. Composite score obtained by adding all the measurements and averaged. The score was tested by the Laser Doppler Flowmetry (LDF). Minimum score is 0 which mean no blood flow detected and there is no maximum value of the score, and higher score mean better blood flow.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Artery Disease', 'Type 2 Diabetes', 'Blood Viscosity', 'Ticagrelor', 'Aspirin'], 'conditions': ['Peripheral Artery Disease', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '31174526', 'type': 'DERIVED', 'citation': 'Rosenson RS, Chen Q, Najera SD, Krishnan P, Lee ML, Cho DJ. Ticagrelor improves blood viscosity-dependent microcirculatory flow in patients with lower extremity arterial disease: the Hema-kinesis clinical trial. Cardiovasc Diabetol. 2019 Jun 7;18(1):77. doi: 10.1186/s12933-019-0882-5.'}]}, 'descriptionModule': {'briefSummary': "The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be superior to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week treatment period. Study participants will be randomized into 3 groups, and each group will receive each of 3 treatments in the cross-over study. At the end of each individual 4 week treatment period the investigators will determine whether there are differences in low and high shear rate dependent viscosity and investigate the effect of the treatment on peripheral arterial blood flow using pulse volume recordings, ankle brachial index and toe pressures. Subjects will be eligible if they have ankle-brachial index less than or equal to 0.85, or if a patient's blood vessels are calcified, patients will have toe-brachial index less than or equal to 0.6 performed using continuous-wave Doppler.", 'detailedDescription': 'Ticagrelor has been shown to significantly reduce the rate of cardiovascular disease (CVD) events and death compared with clopidogrel in patients having prior acute coronary syndrome. A number of outcome studies have demonstrated the risk of major CVD events increased with blood viscosity. Stroke patients and those with stroke risk factors were shown to have chronically elevated blood viscosity relative to healthy controls. Based on prior observations, the rationale for this study is to demonstrate that both aspirin-ticagrelor and ticagrelor monotherapy will be superior to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week treatment period.\n\nThe primary objectives for this study is to: (1) Compare the effect of aspirin-ticagrelor with aspirin in a double blind, randomized, cross-over study design (weeks 1-4, weeks 6-10, and weeks 12-16) on blood viscosity at both low (5 s-¹) and high (300 s-¹) shear rates at the end of each 4-week treatment period; and (2) to compare the effect of ticagrelor mono-therapy with aspirin in a double blind, randomized, cross-over study design (weeks 1-4, weeks 6-10, and weeks 12-16) on blood viscosity at both low (5 s-¹) and high (300 s-¹) at the end of each 4-week treatment.\n\nThe secondary objectives for this study include: (1) a determination as to whether there are differences in low and high shear rate dependent viscosity with treatment by ticagrelor alone and combination aspirin-ticagrelor. Additionally, investigated will be the effect of the treatment on peripheral arterial blood flow using pulse volume recordings, ankle brachial index, and toe pressures.\n\nThe general approach to evaluation of drug efficacy will be through blood samples collected with a standard venipuncture for viscosity testing. Blood viscosity will be measured using an automated scanning capillary tube viscometer across a physiologic range of shear rates of 1-1000 s-1 in increments of 0.1 s-1. Blood viscosity levels at 5 s-1 will be reported as low-shear viscosity, and blood viscosity measurements at 300 s-1 will be reported as high-shear viscosity. Additionally, pulse volume recordings will be simultaneously obtained at the level of the ankle, metatarsal and toe bilaterally according to standard protocol, and Continuous-wave Doppler will be used to determine ankle-brachial indices or toe-brachial indices, and flow velocity profiles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female or male aged ≥ 35 years\n* Type 2 diabetes mellitus\n* Symptomatic PAD\n* Ankle-brachial index ≤ 0.85 or calcified blood vessels with toe-brachial index ≤ 0.6 and/or abnormal post-exercise ankle-brachial index\n* Prior surgical or percutaneous intervention of the peripheral arteries ≥12 months previously with a residual stenoses of ≥50% in a non-dilated artery.\n\nExclusion Criteria:\n\n* Subject is pregnant or breast-feeding\n* Planned revascularization or amputation\n* Known bleeding disorder\n* History of intracranial hemorrhag3\n* Considered at risk of hemorrhagic events\n* Hypersensitivity or allergic reactions to aspirin\n* Concomitant use of anticoagulants such as warfarin, dabigatran, factor Xa inhibitors or antiplatelet drugs such as clopidogrel, dipyridamole and sulfapyridine\n* Subject has a condition or circumstance which would prevent them from adhering to treatment regimens\n* Subject has active infection\n* Subject has an anemia\n* Subject has given blood or received a blood transfusion at any point during the study\n* Subject has polycythemia vera or any hyperviscosity syndrome\n* Subjects with Waldenstrom's macroglobulinemia who have an increased risk of hyperviscosity syndrome\n* Subject has history of severe liver disease, obstructive liver disease such as primary biliary cirrhosis or end-stage renal disease (eGFR \\<30 mL/min/m2)\n* Family members or employees of the investigator or study centers involved in the study\n* Subject has poor diabetes or hypertension control (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)"}, 'identificationModule': {'nctId': 'NCT02325466', 'briefTitle': 'Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease (PAD) Patients With Type 2 Diabetes (T2D)', 'orgStudyIdInfo': {'id': 'GCO 13-1925'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Aspirin/Ticagrelor placebo', 'description': 'aspirin 81 mg daily and ticagrelor placebo twice daily', 'interventionNames': ['Drug: Aspirin', 'Drug: Ticagrelor Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin/Ticagrelor', 'description': 'aspirin 81 mg daily and ticagrelor 90 mg twice daily', 'interventionNames': ['Drug: Aspirin', 'Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin Placebo/Ticagrelor', 'description': 'aspirin placebo daily and ticagrelor 90 mg twice daily', 'interventionNames': ['Drug: Ticagrelor', 'Drug: Aspirin Placebo']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['ASA'], 'description': 'Aspirin 81mg', 'armGroupLabels': ['Aspirin/Ticagrelor', 'Aspirin/Ticagrelor placebo']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'description': 'ticagrelor 90 mg', 'armGroupLabels': ['Aspirin Placebo/Ticagrelor', 'Aspirin/Ticagrelor']}, {'name': 'Aspirin Placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'armGroupLabels': ['Aspirin Placebo/Ticagrelor']}, {'name': 'Ticagrelor Placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'armGroupLabels': ['Aspirin/Ticagrelor placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert Rosenson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Medicine, Cardiology', 'investigatorFullName': 'Robert Rosenson', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}