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Low recruitment / DSMB approval to halt recruitment
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This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 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 |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol | Drug | 25mg PO BID if the HR is elevated at preadmission testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Composite of Cardiovascular Events | the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Hospital stay, ~7 days | |
| Each Individual Endpoint of the Composite of Cardiovascular Events | 30 days |
Inclusion Criteria:
• ≥ 21 years of age
Subjects undergoing open orthopedic surgery of the hip, knee or spine
Surgery is scheduled at least 3 days after PAT visit and no more than 14 days.
High risk subject cohort
Renal insufficiency (creatinine clearance < 60ml/min)
Diabetes
COPD
Hypertension
Active smoker or stopped less than 30 days prior to consent
Cancer (excluding BCC)
Heart Failure
Exclusion Criteria:
• Known intolerance to statins
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Berger, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Hospital for Joint Diseases | New York | New York | 10003 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 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 Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing Atorvastatin: 80mg PO QD at preadmission testing Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling |
| FG001 | Control | Standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 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 Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing Atorvastatin: 80mg PO QD at preadmission testing Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism | Posted | Number | participants | 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 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 Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing Atorvastatin: 80mg PO QD at preadmission testing Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Berger | NYU Langone Health | 212 263 4004 | Jeffrey.Berger@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2015 | May 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D003324 | Coronary Artery Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| D000319 | Adrenergic beta-Antagonists |
| D017706 | Lisinopril |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D000069059 | Atorvastatin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Lisinopril | Drug | 2.5mg PO QD if the HR is elevated at preadmission testing |
|
|
| Atorvastatin | Drug | 80mg PO QD at preadmission testing |
|
|
| Lifestyle counseling | Behavioral | Diet, exercise, medication adherance and smoking counseling |
|
| BG001 | Control | Standard of care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Modified Composite of Cardiovascular Events | the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation | 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. | Posted | 30 days |
|
|
| Other Pre-specified | Length of Stay | Posted | Median | Inter-Quartile Range | days | Hospital stay, ~7 days |
|
|
|
| Other Pre-specified | Each Individual Endpoint of the Composite of Cardiovascular Events | Efforts were made to collect this data from PI, but data analysis was not completed for this outcome measure | Posted | 30 days |
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Control | Standard of care | 0 | 95 | 0 | 95 | 0 | 95 |
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| D014652 |
| Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |