Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT01523366
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2012-01-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pharmacodynamic Study With Ticagrelor in Hispanic 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 AZ-authorized publication or up to 18 months from study completion at all sites.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Total N for the secondary outcome analysis after multiple doses and for PK measures was not the same for 2 hours, 8 hours and end of dosing. Only the first time point total N can be reported via the form. Row titles indicate N's where they differ."}}, '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 Arm', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.', 'otherNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clopidogrel Arm', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.', 'otherNumAtRisk': 39, 'otherNumAffected': 6, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor Arm', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.'}, {'id': 'OG001', 'title': 'Clopidogrel Arm', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '55.9'}, {'value': '201.4', 'groupId': 'OG001', 'lowerLimit': '178.7', 'upperLimit': '224.1'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-167.2', 'ciLowerLimit': '-197.0', 'ciUpperLimit': '-137.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.6', 'estimateComment': 'Ticagrelor minus clopidogrel', '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 after the loading dose', 'description': 'Participants with low (\\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value', 'unitOfMeasure': 'PRU', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor Arm', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.'}, {'id': 'OG001', 'title': 'Clopidogrel Arm', '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': '134.6', 'groupId': 'OG000', 'lowerLimit': '105.1', 'upperLimit': '164.1'}, {'value': '269.8', 'groupId': 'OG001', 'lowerLimit': '238.7', 'upperLimit': '300.8'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '58.8'}, {'value': '202.8', 'groupId': 'OG001', 'lowerLimit': '176.6', 'upperLimit': '229.0'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-135.2', 'ciLowerLimit': '-172.3', 'ciUpperLimit': '-98.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.23', 'estimateComment': 'Ticagrelor minus Clopidogrel', 'groupDescription': 'Analysis at 0.5 hours after the 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': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-168.9', 'ciLowerLimit': '-204.0', 'ciUpperLimit': '-133.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.28', 'estimateComment': 'Ticagrelor minus Clopidogrel', 'groupDescription': 'Analysis at 8 hours after the 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 and 8 hours after the loading dose', 'description': 'Participants with low (\\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value', 'unitOfMeasure': 'PRU', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set'}, {'type': 'SECONDARY', 'title': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ticagrelor Arm', 'description': 'Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.'}, {'id': 'OG001', 'title': 'Clopidogrel Arm', 'description': 'Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.'}], 'classes': [{'title': '2 hours on day 7', 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '49.0'}, {'value': '179.0', 'groupId': 'OG001', 'lowerLimit': '157.7', 'upperLimit': '200.3'}]}]}, {'title': '8 hours on Day 7 -ticagrelor N=36 clopidogrel N=33', 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '60.3'}, {'value': '178.9', 'groupId': 'OG001', 'lowerLimit': '156.5', 'upperLimit': '201.4'}]}]}, {'title': "End of Dosing Interval on Day 8 - N's per 8 hours", 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '73.1'}, {'value': '182.1', 'groupId': 'OG001', 'lowerLimit': '159.5', 'upperLimit': '204.7'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-150.5', 'ciLowerLimit': '-176.9', 'ciUpperLimit': '-124.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.97', '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': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-140.2', 'ciLowerLimit': '-168.4', 'ciUpperLimit': '-111.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.84', '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': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-130.6', 'ciLowerLimit': '-158.0', 'ciUpperLimit': '-103.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.41', '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 the end of dosing interval on Day 8', 'description': 'The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (\\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value', 'unitOfMeasure': 'PRU', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set'}, {'type': 'SECONDARY', 'title': 'Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', '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 hours - pre-dose)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '0,.5 hours after the loading dose', 'categories': [{'measurements': [{'value': '206.7', 'spread': '413.1', 'groupId': 'OG000'}, {'value': '118.6', 'spread': '352.0', 'groupId': 'OG001'}]}]}, {'title': '2 hours after the loading dose - Period 2 N=18', 'categories': [{'measurements': [{'value': '665.4', 'spread': '566.2', 'groupId': 'OG000'}, {'value': '758.5', 'spread': '716.6', 'groupId': 'OG001'}]}]}, {'title': '8 hours after the loading dose', 'categories': [{'measurements': [{'value': '376.9', 'spread': '378.8', 'groupId': 'OG000'}, {'value': '479.6', 'spread': '210.7', 'groupId': 'OG001'}]}]}, {'title': '0 hours after multiple doses', 'categories': [{'measurements': [{'value': '248.8', 'spread': '238.9', 'groupId': 'OG000'}, {'value': '220.1', 'spread': '295.8', 'groupId': 'OG001'}]}]}, {'title': '2 hours after multiple doses', 'categories': [{'measurements': [{'value': '609.3', 'spread': '271.3', 'groupId': 'OG000'}, {'value': '466.5', 'spread': '534.5', 'groupId': 'OG001'}]}]}, {'title': '8 hours after multiple doses', 'categories': [{'measurements': [{'value': '340.4', 'spread': '283.8', 'groupId': 'OG000'}, {'value': '305.2', 'spread': '301.6', 'groupId': 'OG001'}]}]}, {'title': 'End of dosing interval on Day 8 - Period 1 N=17', 'categories': [{'measurements': [{'value': '283.3', 'spread': '438.1', 'groupId': 'OG000'}, {'value': '200.7', 'spread': '268.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose', 'description': 'The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Analysis Set, defined as all participants 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': '18', 'groupId': 'OG000'}, {'value': '19', '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 hours - pre-dose)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': '0,.5 hours after the loading dose', 'categories': [{'measurements': [{'value': '13.6', 'spread': '66.3', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '26.9', 'groupId': 'OG001'}]}]}, {'title': '2 hours after the loading dose - Period 2 N=18', 'categories': [{'measurements': [{'value': '153.2', 'spread': '128.6', 'groupId': 'OG000'}, {'value': '170.8', 'spread': '156.5', 'groupId': 'OG001'}]}]}, {'title': '8 hours after the loading dose', 'categories': [{'measurements': [{'value': '113.8', 'spread': '54.6', 'groupId': 'OG000'}, {'value': '97.7', 'spread': '61.9', 'groupId': 'OG001'}]}]}, {'title': '0 hours after multiple doses', 'categories': [{'measurements': [{'value': '113.3', 'spread': '102.1', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '76.7', 'groupId': 'OG001'}]}]}, {'title': '2 hours after multiple doses', 'categories': [{'measurements': [{'value': '183.4', 'spread': '120.8', 'groupId': 'OG000'}, {'value': '97.4', 'spread': '147.9', 'groupId': 'OG001'}]}]}, {'title': '8 hours after multiple doses', 'categories': [{'measurements': [{'value': '132.8', 'spread': '61.9', 'groupId': 'OG000'}, {'value': '83.5', 'spread': '71.4', 'groupId': 'OG001'}]}]}, {'title': 'End of dosing interval on Day 8 - Period 1 N=17', 'categories': [{'measurements': [{'value': '124.8', 'spread': '56.6', 'groupId': 'OG000'}, {'value': '57.7', 'spread': '83.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose', 'description': 'The SD is a statistic using the log-transformed data and is not the geometric SD.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}]}, '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), 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': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period - 10-14 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not completed at least 7 days treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited from 6 centers in the United States from April 2012 until May 2013.', 'preAssignmentDetails': '53 patients screened; 40 patients randomized; 38 patients completed the study (7, 8, or 9 days of both treatment sequences), and 39 completed follow-up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', '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': '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), 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': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized Analysis Set for demography (N=40) - included all patients who signed informed consent and were randomized into the study. Pharmacodynamic (PD) Analysis Set for outcomes (N=38) - included all patients for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-14', 'studyFirstSubmitDate': '2012-01-30', 'resultsFirstSubmitDate': '2014-05-10', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-03', 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose', 'timeFrame': 'At 2 hours after the loading dose', 'description': 'Participants with low (\\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value'}], 'secondaryOutcomes': [{'measure': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose', 'timeFrame': 'At 0.5 and 8 hours after the loading dose', 'description': 'Participants with low (\\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value'}, {'measure': 'Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 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 the end of dosing interval on Day 8', 'description': 'The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (\\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value'}, {'measure': 'Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses', 'timeFrame': 'Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose', 'description': 'The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.'}, {'measure': 'AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses', 'timeFrame': 'Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose', 'description': 'The SD is a statistic using the log-transformed data and is not the geometric SD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stable Coronary Artery Disease, CAD'], 'conditions': ['Stable Coronary Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=484&filename=D5130L00012_Clinical_Study_Protocol_Redacted_4-9-14_Redacted.pdf', 'label': 'D5130L00012\\_Clinical\\_Study\\_Protocol\\_Redacted'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=484&filename=D5130L00012_CSR_Synopsis_01Apr2014.pdf', 'label': 'CSR\\_Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic 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 Hispanic 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 Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment\n* Females must be post menopausal or surgically sterile Self-identified as Hispanic\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\n* Patients requiring dialysis'}, 'identificationModule': {'nctId': 'NCT01523366', 'briefTitle': 'A Pharmacodynamic Study With Ticagrelor in Hispanic 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 Hispanic Patients With Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'D5130L00012'}}, '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': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'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': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Linden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.62205, 'lon': -74.24459}}], 'overallOfficials': [{'name': 'Glenn Carlson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca PharmaceuticalsRoom C3B-718PO Box 15437Wilmington, DE 19850-5437 USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}