Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 9:19 PM
Study NCT ID:
NCT03317002
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2017-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
Sponsor:
Organization:
Raw JSON
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12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 27, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 12, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 22, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Post procedural sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0.03'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Creatinine-normalized u-LTE4 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '92.55', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '84.32', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '44.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciUpperLimit': '0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciUpperLimit': '0.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Creatinine-normalized u-LTE4 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '92.55', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '84.32', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '44.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciUpperLimit': '0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciUpperLimit': '0.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CFVR at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '23.64', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '39.53', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '33.46', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CFVR at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '28.34', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '31.47', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '33.16', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Summary of Plasma Concentrations of AZD5718', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}], 'classes': [{'title': 'Baseline: 1-8 Hours Post-Dose', 'categories': [{'measurements': [{'value': '611.88', 'spread': '234.50', 'groupId': 'OG000'}, {'value': '47.88', 'spread': '497.86', 'groupId': 'OG001'}]}]}, {'title': '2 weeks (Visit 3): 20-28 Hours Post-Dose', 'categories': [{'measurements': [{'value': '59.36', 'spread': '90.97', 'groupId': 'OG000'}, {'value': '16.57', 'spread': '127.80', 'groupId': 'OG001'}]}]}, {'title': '4 weeks (Visit 4): Pre-Dose', 'categories': [{'measurements': [{'value': '48.00', 'spread': '68.17', 'groupId': 'OG000'}, {'value': '11.01', 'spread': '60.70', 'groupId': 'OG001'}]}]}, {'title': '4 weeks (Visit 4): 0-2 Hours Post-Dose', 'categories': [{'measurements': [{'value': '339.28', 'spread': '243.04', 'groupId': 'OG000'}, {'value': '38.68', 'spread': '159.56', 'groupId': 'OG001'}]}]}, {'title': '4 weeks (Visit 4): 2-4 Hours Post-Dose', 'categories': [{'measurements': [{'value': '919.22', 'spread': '51.26', 'groupId': 'OG000'}, {'value': '148.64', 'spread': '71.86', 'groupId': 'OG001'}]}]}, {'title': '4 weeks (Visit 4): 4-8 Hours Post-Dose', 'categories': [{'measurements': [{'value': '649.09', 'spread': '49.89', 'groupId': 'OG000'}, {'value': '105.40', 'spread': '52.16', 'groupId': 'OG001'}]}]}, {'title': '12 weeks (Visit 4c): Pre-Dose', 'categories': [{'measurements': [{'value': '65.39', 'spread': '91.52', 'groupId': 'OG000'}, {'value': '13.97', 'spread': '88.12', 'groupId': 'OG001'}]}]}, {'title': '16 weeks (Visit 5) - FUP 1 month', 'categories': [{'measurements': [{'value': '0.51', 'spread': '16.39', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '16 weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LAD Hypereamic Flow at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LAD=Left Anterior Descending', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LVEF at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '6.39', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '5.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LVEF=Left Ventricular Ejection Fraction', 'unitOfMeasure': 'percent LVEF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '30.61', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '33.55', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '30.45', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LV=Left Ventricular', 'unitOfMeasure': '1/s', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LV-GLS at Rest at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '2.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LV-GLS = Left Ventricular Global Longitudinal Strain', 'unitOfMeasure': 'Percent LV-GLS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LV-GCS at Rest at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '5.40', 'groupId': 'OG001'}, {'value': '-1.88', 'spread': '6.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LV-GCS = Left Ventricular Global Circumferential Strain', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LAD Resting Mean Diastolic Flow Velocity at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'OG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '23.31', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '23.68', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '20.14', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LAD=Left Anterior Descending', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed differs from participant flow module due to missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'FG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted in 3 countries at 9 sites; 3 in Denmark, 2 in Finland and 4 in Sweden.', 'preAssignmentDetails': 'Participants underwent a screening visit between 2 and within 27 days before receiving the first dose of IP.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD5718 (200 mg)', 'description': 'AZD5718 (200 mg)'}, {'id': 'BG001', 'title': 'AZD5718 (50 mg)', 'description': 'AZD5718 (50 mg)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '8.21', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '8.12', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '8.51', 'groupId': 'BG002'}, {'value': '61.5', 'spread': '8.26', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-11', 'size': 2923367, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-29T07:20', 'hasProtocol': True}, {'date': '2020-05-18', 'size': 22760328, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-29T07:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2017-10-05', 'resultsFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-29', 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Creatinine-normalized u-LTE4 at Week 4', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Creatinine-normalized u-LTE4 at Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine'}, {'measure': 'Change From Baseline in CFVR at Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)'}, {'measure': 'Change From Baseline in CFVR at Week 4', 'timeFrame': 'Baseline and 4 weeks', 'description': 'CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)'}, {'measure': 'Summary of Plasma Concentrations of AZD5718', 'timeFrame': '16 weeks'}, {'measure': 'Change From Baseline in LAD Hypereamic Flow at 4 Weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LAD=Left Anterior Descending'}, {'measure': 'Change From Baseline in LVEF at 4 Weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LVEF=Left Ventricular Ejection Fraction'}, {'measure': 'Change From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 Weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LV=Left Ventricular'}, {'measure': 'Change From Baseline in LV-GLS at Rest at Week 4', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LV-GLS = Left Ventricular Global Longitudinal Strain'}, {'measure': 'Change From Baseline in LV-GCS at Rest at Week 4', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LV-GCS = Left Ventricular Global Circumferential Strain'}, {'measure': 'Change From Baseline in LAD Resting Mean Diastolic Flow Velocity at 4 Weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'LAD=Left Anterior Descending'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '35842004', 'type': 'DERIVED', 'citation': 'Prescott E, Angeras O, Erlinge D, Grove EL, Hedman M, Jensen LO, Pernow J, Saraste A, Akerblom A, Svedlund S, Rudvik A, Knochel J, Lindstedt EL, Garkaviy P, Gan LM, Gabrielsen A. Safety and efficacy of the 5-lipoxygenase-activating protein inhibitor AZD5718 in patients with recent myocardial infarction: The phase 2a FLAVOUR study. Int J Cardiol. 2022 Oct 15;365:34-40. doi: 10.1016/j.ijcard.2022.07.016. Epub 2022 Jul 14.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D7550C00003&attachmentIdentifier=bfc8ef9d-0ec7-4ad9-9153-27fb6e2d880e&fileName=Statistical_Analysis_Plan_redacted.pdf&versionIdentifier=', 'label': 'redacted Statistical Analysis Plan'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D7550C00003&attachmentIdentifier=72c1cf18-0bad-4d45-a0cd-640350986d43&fileName=Clinical_Study_Protocol_redacted.pdf&versionIdentifier=', 'label': 'redacted Clinical Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in patients with CAD. The study will be conducted at approximately 10 centres in 3 countries. Approximately 138 CAD patients will be randomized to AZD5718 or placebo (treatment duration 12 weeks).', 'detailedDescription': 'This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in patients with CAD. The study will be conducted at approximately 10 centres in 3 countries (Denmark, Finland and Sweden).\n\nPatients suitable for the study will be identified and screened for eligibility after being hospitalized for Acute Coronary Syndrome (ACS) (Visit 1) comprising ST Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (non-STEMI). At Visit 1, after signing informed consent, study measurements will take place at days 1, 2, 3 and 5 post ACS, where feasible. It is planned that approximately 138 CAD patients will be randomized to ensure at least 66 evaluable patients receiving AZD5718 Dose B or placebo are included with 12 weeks treatment. For supporting dose selection in future studies, a treatment arm with 28 randomized patients receiving AZD5718 Dose A is included in the study. The study was originally designed to be a 4-week study and was amended to be a 12-week study. Therefore, the total number of patients is greater than required for a 12 weeks study (about 100), since some patients will only have 4 weeks of treatment.\n\nAn evaluable patient is defined as a patient with a valid Coronary Flow Velocity Reserve (CFVR) measurement at Visit 2 and one post baseline visit as judged by the CFVR Core lab.\n\nOn Day 1 (Visit 2), 7 to 28 days after the ACS event, patients willing to participate in the study will complete the screening procedure and, if eligible, be randomized. Treatment duration will be 12 weeks. During the treatment phase, patients will come in to the clinic for study measurements at 2 weeks (visit 3), 4 weeks (visit 4), 8 weeks (visit 4b) and 12 weeks (visit 4c).\n\nA follow-up visit (Visit 5) will be performed at 4 weeks (±4 days) after last dose in order to ensure safety and well-being of the patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females of non-childbearing potential\n* Age ≥18 to ≤75\n* Body Mass Index (BMI) ≥18 to ≤35 kg/m2\n* CAD patients, here defined as:\n\nACS 7-28 days prior to study randomization (ACS defined as STEMI, non STEMI event documented by Electrocardiogram (ECG), cardiac enzymes \\[troponin\\] and angiogram) Provision of signed and dated, written informed consent prior to any study specific procedures\n\nExclusion Criteria:\n\n* Uncontrolled Type 1 or Type 2 diabetes defined as haemoglobin A1c (HbA1c) Diabetes\n* Control and Complications Trial (DCCT)\\> 9% or International Federation of Clinical Chemistry (IFCC) \\>74.9 mmol/mol\n* Patients with atrial fibrillation (chronic or current) or history of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia or sick sinus syndrome or Atrioventricular blockage degree 2-3\n* Prior coronary artery by-pass graft (Coronary artery bypass grafting) to Left Anterior Descending artery (LAD)\n* Left ventricle ejection fraction \\< 30%\n* Unacceptable level of angina despite maximal medical therapy or unstable angina at entry\n* Canadian Cardiovascular Society (CCS) ≥ 3 (Visit 1 or Visit 2)\n* Stroke within the previous 6 months from ACS or ongoing treatment with Persantin or Asasantin\n* Chronic use of anticoagulants on therapeutic dose (not including thrombosis prophylaxis) during the study\n* Planned additional cardiac intervention (e.g., Percutaneous coronary intervention (PCI), Coronary artery bypass grafting (CABG) within next 6 months\n* New York Heart Association (NYHA) class III-IV heart failure or decompensated heart failure at discharge or hospitalization for exacerbation of chronic heart failure within the previous 3 months from ACS\n* Previously known severe renal disease (Chronic Kidney Disease (CKD) stage 4 or 5) or previously known creatinine clearance calculated by Cockcroft Gault equation \\<30 ml/min\\*m2\n* Known allergy to adenosine and mannitol, or experience of previous adverse effects of adenosine stress testing.\n* Participation in another interventional clinical study with an investigational pharmaceutical product during the last 3 months also including drug eluting stents.'}, 'identificationModule': {'nctId': 'NCT03317002', 'acronym': 'FLAVOUR', 'briefTitle': 'AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 12-week, Randomized, Single-blind, Placebo-controlled, Multi-centre, Parallel Group, Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 After 4 and 12-weeks of Treatment in Patients With Coronary Artery Disease (CAD)', 'orgStudyIdInfo': {'id': 'D7550C00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD5718 Dose A', 'description': 'AZD5718 Dose A once daily', 'interventionNames': ['Drug: AZD5718']}, {'type': 'EXPERIMENTAL', 'label': 'AZD5718 Dose B', 'description': 'AZD5718 Dose B once daily', 'interventionNames': ['Drug: AZD5718']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD5718', 'type': 'DRUG', 'description': 'Oral dose of AZD5718 (tablet)', 'armGroupLabels': ['AZD5718 Dose A']}, {'name': 'AZD5718', 'type': 'DRUG', 'description': 'Oral dose of AZD5718 (tablet)', 'armGroupLabels': ['AZD5718 Dose B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo (tablet)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Research Site', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Research Site', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '222 42', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}