Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-27 @ 6:38 AM
Study NCT ID:
NCT01523392
Status:
COMPLETED
Last Update Posted:
2014-10-08
First Post:
2012-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pharmacodynamic Study With Ticagrelor in African American Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'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'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '1-800-236-9933', 'title': 'Tomas LG Andersson, MD, PhD', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'An Investigator agrees to provide a copy of the publication to AstraZeneca (AZ) for review at least 60 days in advance of the submission for publication. The Investigators in the Multi-Center (MC) study agree to postpone MC publications until the earlier of the first AstraZeneca-authorized publication or up to eighteen months from study completion at all sites.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant).', 'description': 'Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.', 'eventGroups': [{'id': 'EG000', 'title': 'Ticagrelor', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days', 'otherNumAtRisk': 34, 'otherNumAffected': 5, 'seriousNumAtRisk': 34, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Clopidogrel', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days', 'otherNumAtRisk': 31, 'otherNumAffected': 2, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Haemorroidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Application site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}, {'term': 'Vaginal haemmorhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'notes': 'Occurred 14 days after the last dose of ticagrelor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V16.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days'}, {'id': 'OG001', 'title': 'Clopidogrel', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '50.2'}, {'value': '211.2', 'groupId': 'OG001', 'lowerLimit': '188.3', 'upperLimit': '234.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-183.6', 'ciLowerLimit': '-213.9', 'ciUpperLimit': '-153.3', 'pValueComment': 'Model contained treatment group, period, and sequence as fixed effects and a random effect for patient within sequence', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.68', 'estimateComment': 'Ticagrelor minus clopidogrel', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 2 hours after the loading dose', 'unitOfMeasure': 'PRU', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set (N=32) - included all participants for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel'}, {'type': 'SECONDARY', 'title': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days'}, {'id': 'OG001', 'title': 'Clopidogrel', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days'}], 'classes': [{'title': '0.5 hours', 'categories': [{'measurements': [{'value': '166.3', 'groupId': 'OG000', 'lowerLimit': '137.9', 'upperLimit': '194.8'}, {'value': '270.1', 'groupId': 'OG001', 'lowerLimit': '241.3', 'upperLimit': '298.8'}]}]}, {'title': '8 hours (N=28 ticagrelor, N=27 clopidogrel)', 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '50.2'}, {'value': '192.6', 'groupId': 'OG001', 'lowerLimit': '169.3', 'upperLimit': '215.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-103.8', 'ciLowerLimit': '-142.5', 'ciUpperLimit': '-65.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.79', 'estimateComment': 'Ticagrelor minus clopidogrel', 'groupDescription': 'Analysis at 0.5 hours after loading dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-165.3', 'ciLowerLimit': '-197.4', 'ciUpperLimit': '-133.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.45', 'estimateComment': 'Ticagrelor minus clopidogrel', 'groupDescription': 'Analysis at 8 hours after loading dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 0.5 hour and 8 hours after the loading dose', 'unitOfMeasure': 'PRU', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'PD Analysis Set'}, {'type': 'SECONDARY', 'title': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days'}, {'id': 'OG001', 'title': 'Clopidogrel', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days'}], 'classes': [{'title': '2 hours on Day 7 (N=27 for clopidogrel)', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '44.4'}, {'value': '157.8', 'groupId': 'OG001', 'lowerLimit': '135.9', 'upperLimit': '179.8'}]}]}, {'title': '8 hours on Day 7', 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '49.2'}, {'value': '146.5', 'groupId': 'OG001', 'lowerLimit': '125.6', 'upperLimit': '167.4'}]}]}, {'title': 'End of dosing interval on Day 8', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '60.7'}, {'value': '172.7', 'groupId': 'OG001', 'lowerLimit': '151.2', 'upperLimit': '194.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-135.0', 'ciLowerLimit': '-160.4', 'ciUpperLimit': '-109.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.35', 'estimateComment': 'Ticagrelor minus clopidogrel', 'groupDescription': 'Analysis at 2 hours on Day 7 after multiple doses', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-118.1', 'ciLowerLimit': '-143.9', 'ciUpperLimit': '-92.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.55', 'estimateComment': 'Ticagrelor minus clopidogrel', 'groupDescription': 'Analysis at 8 hours on Day 7 after multiple doses', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-133.4', 'ciLowerLimit': '-159.7', 'ciUpperLimit': '-107.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.77', 'estimateComment': 'Ticagrelor minus clopidogrel', 'groupDescription': 'Analysis at end of dosing interval on Day 8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8', 'unitOfMeasure': 'PRU', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'PD Analysis Set'}, {'type': 'SECONDARY', 'title': 'Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor (Treatment Period 1)', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days'}, {'id': 'OG001', 'title': 'Ticagrelor (Treatment Period 2)', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days'}], 'classes': [{'title': 'Baseline (0 pre-dose hours)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '0.5 hours after the loading dose', 'categories': [{'measurements': [{'value': '206.6', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': '2 hours after the loading dose', 'categories': [{'measurements': [{'value': '1167.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '756.9', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '8 hours after the loading dose - Period 1 N=19', 'categories': [{'measurements': [{'value': '395.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '141.9', 'spread': '12.1', 'groupId': 'OG001'}]}]}, {'title': '0 hours after multiple doses - Period 1 N=18', 'categories': [{'measurements': [{'value': '168.4', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '187.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': '2 hours after multiple doses - Period 1 N=18', 'categories': [{'measurements': [{'value': '324.6', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '608.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '8 hours after multiple doses - Period 1 N=18', 'categories': [{'measurements': [{'value': '179.2', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '311.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'End of dosing interval on Day 8 - Period 1 N=18', 'categories': [{'measurements': [{'value': '284.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '295.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose', 'description': 'The standard deviation (SD) is the geometric SD', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available'}, {'type': 'SECONDARY', 'title': 'AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor (Treatment Period 1)', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days'}, {'id': 'OG001', 'title': 'Ticagrelor (Treatment Period 2)', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days'}], 'classes': [{'title': 'Baseline (0 pre-dose hours)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '0.5 hours after the loading dose', 'categories': [{'measurements': [{'value': '9.8', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': '2 hours after the loading dose', 'categories': [{'measurements': [{'value': '222.6', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '150.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': '8 hours after the loading dose - Period 1 N=19', 'categories': [{'measurements': [{'value': '119.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': '0 hours after multiple doses - Period 1 N=18', 'categories': [{'measurements': [{'value': '93.2', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '2 hours after multiple doses - Period 1 N=18', 'categories': [{'measurements': [{'value': '136.7', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '172.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': '8 hours after multiple doses - Period 1 N=18', 'categories': [{'measurements': [{'value': '89.8', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '112.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'End of dosing interval on Day 8 - Period 1 N=18', 'categories': [{'measurements': [{'value': '140.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '110.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose', 'description': 'The standard deviation (SD) is the geometric SD', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence', 'description': 'Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2)'}, {'id': 'FG001', 'title': 'Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not complete 7-9 days of treatment.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period - 10 to 14 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 patient did not complete 7-9 days of Period 1 treatment but continued in the Washout and Period 2', 'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited from 8 participating centers in the United States from 28 March 2012 until 04 September 2013', 'preAssignmentDetails': '50 patients screened; 34 patients randomized; 30 patients completed the study (7, 8, or 9 days of both treatments), and 31 completed follow-up'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 2)'}, {'id': 'BG001', 'title': 'Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '>=18 to <65 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized Analysis Set for demography (N=34) - included all patients who signed informed consent and were randomized into the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-30', 'studyFirstSubmitDate': '2012-01-30', 'resultsFirstSubmitDate': '2014-09-22', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-22', 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose', 'timeFrame': 'At 2 hours after the loading dose'}], 'secondaryOutcomes': [{'measure': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose', 'timeFrame': 'At 0.5 hour and 8 hours after the loading dose'}, {'measure': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8', 'timeFrame': 'At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8'}, {'measure': 'Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses', 'timeFrame': 'Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose', 'description': 'The standard deviation (SD) is the geometric SD'}, {'measure': 'AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses', 'timeFrame': 'Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose', 'description': 'The standard deviation (SD) is the geometric SD'}]}, 'conditionsModule': {'keywords': ['Stable Coronary Artery Disease, CAD'], 'conditions': ['Stable Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '26152562', 'type': 'DERIVED', 'citation': 'Waksman R, Maya J, Angiolillo DJ, Carlson GF, Teng R, Caplan RJ, Ferdinand KC. Ticagrelor Versus Clopidogrel in Black Patients With Stable Coronary Artery Disease: Prospective, Randomized, Open-Label, Multiple-Dose, Crossover Pilot Study. Circ Cardiovasc Interv. 2015 Jul;8(7):e002232. doi: 10.1161/CIRCINTERVENTIONS.114.002232.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=485&filename=D5130L00013_Study_Synopsis.pdf', 'label': 'D5130L00013\\_Study\\_Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.', 'detailedDescription': 'A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in African American Patients with Stable Coronary Artery Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent before initiation of any study-related procedures\n* Male or female patients aged 18 years or older\n* Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment\n* Females must be post menopausal or surgically sterile Self-identified as African American\n\nExclusion Criteria:\n\n* Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period\n* Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment\n* Current smokers, including the use of tobacco containing products in the past 1 month of randomization Patients required dialysis'}, 'identificationModule': {'nctId': 'NCT01523392', 'briefTitle': 'A Pharmacodynamic Study With Ticagrelor in African American Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in African American Patients With Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'D5130L00013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ticagrelor', 'interventionNames': ['Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel', 'interventionNames': ['Drug: Clopidogrel']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'description': 'Min - 90mg/Max - 180mg tablets (loading dose)', 'armGroupLabels': ['Ticagrelor']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': '75mg (once daily)/Max - 600mg tablets (loading dose)', 'armGroupLabels': ['Clopidogrel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}], 'overallOfficials': [{'name': 'Glenn Carlson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Pharmaceuticals Room C3B-718PO Box 15437 Wilmington, DE 19850-5437 USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}