Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-24 @ 4:55 PM
Study NCT ID:
NCT01837069
Status:
TERMINATED
Last Update Posted:
2020-07-27
First Post:
2013-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risk Factor Control Before Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jeffrey.Berger@nyulangone.org', 'phone': '212 263 4004', 'title': 'Jeffrey Berger', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated\n\nMetoprolol: 25mg PO BID if the HR is elevated at preadmission testing\n\nLisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing\n\nAtorvastatin: 80mg PO QD at preadmission testing\n\nLifestyle counseling: Diet, exercise, medication adherance and smoking counseling', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Standard of care', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated\n\nMetoprolol: 25mg PO BID if the HR is elevated at preadmission testing\n\nLisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing\n\nAtorvastatin: 80mg PO QD at preadmission testing\n\nLifestyle counseling: Diet, exercise, medication adherance and smoking counseling'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Composite of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated\n\nMetoprolol: 25mg PO BID if the HR is elevated at preadmission testing\n\nLisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing\n\nAtorvastatin: 80mg PO QD at preadmission testing\n\nLifestyle counseling: Diet, exercise, medication adherance and smoking counseling'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'timeFrame': '30 days', 'description': 'the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data are available for this Outcome Measure. Multiple efforts were made to obtain the data from the PI but were unsuccessful, therefore, data cannot be reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated\n\nMetoprolol: 25mg PO BID if the HR is elevated at preadmission testing\n\nLisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing\n\nAtorvastatin: 80mg PO QD at preadmission testing\n\nLifestyle counseling: Diet, exercise, medication adherance and smoking counseling'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital stay, ~7 days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Each Individual Endpoint of the Composite of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated\n\nMetoprolol: 25mg PO BID if the HR is elevated at preadmission testing\n\nLisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing\n\nAtorvastatin: 80mg PO QD at preadmission testing\n\nLifestyle counseling: Diet, exercise, medication adherance and smoking counseling'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care'}], 'timeFrame': '30 days', 'reportingStatus': 'POSTED', 'populationDescription': 'Efforts were made to collect this data from PI, but data analysis was not completed for this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated\n\nMetoprolol: 25mg PO BID if the HR is elevated at preadmission testing\n\nLisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing\n\nAtorvastatin: 80mg PO QD at preadmission testing\n\nLifestyle counseling: Diet, exercise, medication adherance and smoking counseling'}, {'id': 'FG001', 'title': 'Control', 'description': 'Standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated\n\nMetoprolol: 25mg PO BID if the HR is elevated at preadmission testing\n\nLisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing\n\nAtorvastatin: 80mg PO QD at preadmission testing\n\nLifestyle counseling: Diet, exercise, medication adherance and smoking counseling'}, {'id': 'BG001', 'title': 'Control', 'description': 'Standard of care'}, {'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': '103', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': '# Unknown or not reported', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-05', 'size': 477859, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-20T11:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'whyStopped': 'Low recruitment / DSMB approval to halt recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2013-04-12', 'resultsFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-20', 'studyFirstPostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'Hospital stay, ~7 days'}, {'measure': 'Each Individual Endpoint of the Composite of Cardiovascular Events', 'timeFrame': '30 days'}], 'primaryOutcomes': [{'measure': 'Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Modified Composite of Cardiovascular Events', 'timeFrame': '30 days', 'description': 'the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabetes', 'Coronary Artery Disease', 'Peripheral Vascular Disease'], 'conditions': ['Osteoarthritis', 'Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.', 'detailedDescription': 'OPTIMIZE - OS (Optimization of Pre-surgical Testing with an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events - Orthopedic Surgery) trial is to determine the best management strategy for patients undergoing orthopedic surgery. OPTIMIZE will be a prospective randomized trial that will enroll patients during pre-surgical testing before orthopedic surgery. This trial will investigate different strategies aimed at lowering cardiovascular events following orthopedic surgery. The study will compare an intensive multifactorial intervention comprising behavioral modification and polypharmacologic therapy aimed at several modifiable risk factors versus usual care. The trial hypothesis is that a personalized optimization approach is superior to usual care in reducing a composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism or thrombosis requiring reoperation at 30-days. Secondary endpoints include length of stay, major bleeding, each individual endpoint from the primary endpoint, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • ≥ 21 years of age\n\n * Subjects undergoing open orthopedic surgery of the hip, knee or spine\n * Surgery is scheduled at least 3 days after PAT visit and no more than 14 days.\n * High risk subject cohort\n\n * Coronary artery disease, or\n * Cerebrovascular disease (prior stroke, TIA or carotid artery disease (\\>70% stenosis), or\n * Peripheral artery disease, or\n * Prior Venous thromboembolism or arterial thromboembolism, or\n * Age ≥ 60 years and 2 of the following\n * Renal insufficiency (creatinine clearance \\< 60ml/min)\n * Diabetes\n * COPD\n * Hypertension\n * Active smoker or stopped less than 30 days prior to consent\n * Cancer (excluding BCC)\n * Heart Failure\n\nExclusion Criteria:\n\n* • Known intolerance to statins\n\n * Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or rosuvastatin/crestor 40mg daily)\n * Bilateral renal artery stenosis\n * End stage renal disease (receiving dialysis or CrCl \\<30ml/min)\n * Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin receptor blocker (e.g. angioedema, hyperkalemia)\n * Known allergy or intolerance to beta blockers\n * Known sick sinus syndrome not treated with permanent pacemaker\n * Known greater than first degree AV block not treated with a pacemaker\n * Excessive alcohol intake\n * Acute Coronary Syndrome requiring hospitalization within 1 month\n * Stroke within 1 month\n * Known pregnancy\n * Severe co-morbid condition with life expectancy \\< 6 months\n * Inability to give informed consent or adhere to follow-up as per protocol\n * Current participation in another investigational drug or device trial'}, 'identificationModule': {'nctId': 'NCT01837069', 'acronym': 'OPTMIZE-OS', 'briefTitle': 'Risk Factor Control Before Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery', 'orgStudyIdInfo': {'id': '12-02407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated', 'interventionNames': ['Drug: Metoprolol', 'Drug: Lisinopril', 'Drug: Atorvastatin', 'Behavioral: Lifestyle counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}], 'interventions': [{'name': 'Metoprolol', 'type': 'DRUG', 'otherNames': ['Beta blocker'], 'description': '25mg PO BID if the HR is elevated at preadmission testing', 'armGroupLabels': ['Treatment']}, {'name': 'Lisinopril', 'type': 'DRUG', 'otherNames': ['ACE inhibitor'], 'description': '2.5mg PO QD if the HR is elevated at preadmission testing', 'armGroupLabels': ['Treatment']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Statin'], 'description': '80mg PO QD at preadmission testing', 'armGroupLabels': ['Treatment']}, {'name': 'Lifestyle counseling', 'type': 'BEHAVIORAL', 'description': 'Diet, exercise, medication adherance and smoking counseling', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Hospital for Joint Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey Berger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}