Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
198 participants
INTERVENTIONAL
2014-02-28
2018-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Control
Standard of care
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Coronary artery disease, or
* Cerebrovascular disease (prior stroke, TIA or carotid artery disease (\>70% stenosis), or
* Peripheral artery disease, or
* Prior Venous thromboembolism or arterial thromboembolism, or
* Age ≥ 60 years and 2 of the following
* 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
* Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or rosuvastatin/crestor 40mg daily)
* Bilateral renal artery stenosis
* End stage renal disease (receiving dialysis or CrCl \<30ml/min)
* Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin receptor blocker (e.g. angioedema, hyperkalemia)
* Known allergy or intolerance to beta blockers
* Known sick sinus syndrome not treated with permanent pacemaker
* Known greater than first degree AV block not treated with a pacemaker
* Excessive alcohol intake
* Acute Coronary Syndrome requiring hospitalization within 1 month
* Stroke within 1 month
* Known pregnancy
* Severe co-morbid condition with life expectancy \< 6 months
* Inability to give informed consent or adhere to follow-up as per protocol
* Current participation in another investigational drug or device trial
21 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Berger, MD
Role: PRINCIPAL_INVESTIGATOR
NYU School of Medicine
Locations
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NYU Hospital for Joint Diseases
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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12-02407
Identifier Type: -
Identifier Source: org_study_id
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