Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT01175018
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2010-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anakinra to Prevent Adverse Post-infarction Remodeling (2)
Sponsor:
Organization:
Raw JSON
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Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aabbate@mcvh-vcu.edu', 'phone': '804-828-0513', 'title': 'Antonio Abbate', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily', 'otherNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution', 'otherNumAtRisk': 15, 'otherNumAffected': 8, 'seriousNumAtRisk': 15, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Bleeding (not serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (not serious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New onset heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Serious infection', 'notes': 'requiring or prolonging hospital admission, or requiring intravenous antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent myocardial infarction or repeat percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac rupture', 'notes': 'Cardiac rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '3'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-4.5', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '10-14 weeks minus baseline', 'description': 'Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.', 'unitOfMeasure': 'mL/m2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.'}, {'type': 'SECONDARY', 'title': 'Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily\n\nAnakinra: Anakinra 100 mg s.c. daily for 14 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution\n\nPlacebo: 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '10'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-12', 'upperLimit': '17'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '10-14 weeks', 'unitOfMeasure': 'mL/m2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-13', 'upperLimit': '1'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '10-14 weeks', 'unitOfMeasure': 'ml*kg^-1*min^-1', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'description': 'Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events in Each Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '11'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '10-14 weeks', 'unitOfMeasure': '% (absolute change)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 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'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '2'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '-1'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '10-14 weeks', 'unitOfMeasure': '(no units; ratio of values)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml 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'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Deaths in Each Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'unitOfMeasure': 'deaths', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Requiring Withdrawal in Each Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-14 weeks', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': '0.67 ml of sodium chloride (NaCl) 0.9% solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': '0.67 ml of NaCl 0.9% solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '12', 'groupId': 'BG000'}, {'value': '58', 'spread': '12', 'groupId': 'BG001'}, {'value': '59', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2010-07-30', 'resultsFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-09', 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices', 'timeFrame': '10-14 weeks minus baseline', 'description': 'Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.'}], 'secondaryOutcomes': [{'measure': 'Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging', 'timeFrame': '10-14 weeks'}, {'measure': 'Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)', 'timeFrame': '10-14 weeks'}, {'measure': 'Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks', 'timeFrame': '10-14 weeks'}, {'measure': 'Incidence of Heart Failure', 'timeFrame': '10-14 weeks', 'description': 'Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure'}, {'measure': 'Number of Adverse Events in Each Group', 'timeFrame': '10-14 weeks'}, {'measure': 'Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)', 'timeFrame': '10-14 weeks'}, {'measure': 'Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging', 'timeFrame': '10-14 weeks'}, {'measure': 'Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks', 'timeFrame': '10-14 weeks'}, {'measure': 'Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)', 'timeFrame': '10-14 weeks'}, {'measure': 'Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging', 'timeFrame': '10-14 weeks'}, {'measure': 'Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)', 'timeFrame': '10-14 weeks'}, {'measure': 'Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%', 'timeFrame': '10-14 weeks'}, {'measure': 'Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%', 'timeFrame': '10-14 weeks'}, {'measure': 'Number of Deaths in Each Group', 'timeFrame': '10-14 weeks'}, {'measure': 'Number of Adverse Events Requiring Withdrawal in Each Group', 'timeFrame': '10-14 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Heart Failure', 'Cardiac Remodeling'], 'conditions': ['Acute Myocardial Infarction', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '20451681', 'type': 'BACKGROUND', 'citation': 'Abbate A, Kontos MC, Grizzard JD, Biondi-Zoccai GG, Van Tassell BW, Robati R, Roach LM, Arena RA, Roberts CS, Varma A, Gelwix CC, Salloum FN, Hastillo A, Dinarello CA, Vetrovec GW; VCU-ART Investigators. Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University Anakinra Remodeling Trial [VCU-ART] Pilot study). Am J Cardiol. 2010 May 15;105(10):1371-1377.e1. doi: 10.1016/j.amjcard.2009.12.059. Epub 2010 Apr 2.'}, {'pmid': '23453459', 'type': 'RESULT', 'citation': 'Abbate A, Van Tassell BW, Biondi-Zoccai G, Kontos MC, Grizzard JD, Spillman DW, Oddi C, Roberts CS, Melchior RD, Mueller GH, Abouzaki NA, Rengel LR, Varma A, Gambill ML, Falcao RA, Voelkel NF, Dinarello CA, Vetrovec GW. Effects of interleukin-1 blockade with anakinra on adverse cardiac remodeling and heart failure after acute myocardial infarction [from the Virginia Commonwealth University-Anakinra Remodeling Trial (2) (VCU-ART2) pilot study]. Am J Cardiol. 2013 May 15;111(10):1394-400. doi: 10.1016/j.amjcard.2013.01.287. Epub 2013 Feb 27.'}, {'pmid': '25482680', 'type': 'DERIVED', 'citation': 'Abbate A, Kontos MC, Abouzaki NA, Melchior RD, Thomas C, Van Tassell BW, Oddi C, Carbone S, Trankle CR, Roberts CS, Mueller GH, Gambill ML, Christopher S, Markley R, Vetrovec GW, Dinarello CA, Biondi-Zoccai G. Comparative safety of interleukin-1 blockade with anakinra in patients with ST-segment elevation acute myocardial infarction (from the VCU-ART and VCU-ART2 pilot studies). Am J Cardiol. 2015 Feb 1;115(3):288-92. doi: 10.1016/j.amjcard.2014.11.003. Epub 2014 Nov 13.'}, {'pmid': '25121719', 'type': 'DERIVED', 'citation': 'Sonnino C, Christopher S, Oddi C, Toldo S, Falcao RA, Melchior RD, Mueller GH, Abouzaki NA, Varma A, Gambill ML, Van Tassell BW, Dinarello CA, Abbate A. Leukocyte activity in patients with ST-segment elevation acute myocardial infarction treated with anakinra. Mol Med. 2014 Nov 18;20(1):486-9. doi: 10.2119/molmed.2014.00121.'}, {'pmid': '24467979', 'type': 'DERIVED', 'citation': 'Falcao RA, Christopher S, Oddi C, Reznikov L, Grizzard JD, Abouzaki NA, Varma A, Van Tassell BW, Dinarello CA, Abbate A. Interleukin-10 in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2014 Mar 1;172(1):e6-8. doi: 10.1016/j.ijcard.2013.12.126. Epub 2014 Jan 5. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.pauleyheart.vcu.edu', 'label': 'VCU Pauley Heart Center'}]}, 'descriptionModule': {'briefSummary': 'Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.\n\nThe initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. The investigators propose that an antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory response and lead to a more favorable cardiac remodeling process.', 'detailedDescription': 'Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.\n\nThe initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. Interleukin-1 (IL-1) is the prototypical inflammatory cytokine involved in the tissue response to injury. In the experimental model of large anterior wall AMI in the mouse, IL-1 blockade using anakinra, a recombinant human IL-1 receptor antagonist ameliorates cardiac remodeling and improves survival following AMI. Although the mouse AMI model is helpful in understanding the events leading to adverse post-infarction cardiac remodeling and heart failure, the exact role of IL-1 in patients with AMI has not been completely characterized. The investigators propose to address this question by studying patients presenting with ST-segment elevation AMI (STEMI). Such patients are at high risk for in-hospital and long-term mortality and display several markers of inflammation. The investigators hypothesize that IL-1 blockade in patients STEMI with will limit the acute inflammatory response and prevent adverse cardiac remodeling, heart failure, and related morbidity.\n\nThe investigators hypothesize that treatment with anakinra will lead to more favorable cardiac remodeling. Left ventricular end-systolic volume index (LVESVi) is the preferred clinical marker of adverse cardiac remodeling and a strong predictor of heart failure-related mortality in patients with STEMI, and will be used as primary endpoint of the study. The investigators propose that anakinra will reduce the change in LVESVi from baseline to 10-14 weeks after STEMI, and will prevent, at least in part, other changes in cardiac function and exercise tolerance associated with adverse cardiac remodeling and heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with STEMI will be asked to enroll according to the following inclusion criteria:\n\n * age \\> 18 years,\n * acute (\\<12 h) onset of chest pain associated with ST segment elevation (\\>2 mm) in 2 or more anatomically contiguous leads at ECG,\n * and successful primary percutaneous coronary intervention.\n\nExclusion criteria:\n\n* inability to give informed consent,\n* late presentation (\\>12 h),\n* unsuccessful revascularization procedure,\n* hemodynamic instability including hypotension,\n* prior Q-wave AMI,\n* end-stage congestive heart failure (American Heart Association \\[AHA\\]/American College of Cardiology \\[ACC\\] class C-D, New York Heart Association IV), severe left ventricular dysfunction (EF\\<20%),\n* severe valvular heart disease,\n* pregnancy, dye allergy or contraindications to cardiac angiography and/or magnetic resonance imaging, coagulopathy (INR\\>1.5 or platelet count\\<50000/mm3),\n* recent (\\<14 days) use of anti-inflammatory drugs (not including NSAIDs),\n* chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), and malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study.'}, 'identificationModule': {'nctId': 'NCT01175018', 'acronym': 'VCU-ART2', 'briefTitle': 'Anakinra to Prevent Adverse Post-infarction Remodeling (2)', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Anakinra to Prevent Adverse Post-infarction Remodeling (2)', 'orgStudyIdInfo': {'id': 'AHA 10SDG3030051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anakinra', 'description': 'Anakinra 100 mg injectable subcutaneously daily', 'interventionNames': ['Drug: Anakinra']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.67 ml of sodium chloride (NaCl) 0.9% solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Anakinra', 'type': 'DRUG', 'otherNames': ['Kineret'], 'description': 'Anakinra 100 mg s.c. daily for 14 days', 'armGroupLabels': ['Anakinra']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['NaCl 0.9%'], 'description': '0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Antonio Abbate, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}