Risk Factor Control Before Orthopedic Surgery

Phase 4

Terminated

• Conditions: Cardiovascular Disease; Osteoarthritis
• Interventions: Drug: Metoprolol; Drug: Lisinopril; Drug: Atorvastatin; Behavioral: Lifestyle counseling

• Registration Number: NCT01837069
• Lead Sponsor: NYU Langone Health

Brief Summary

This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Study Start: 2014-02
• Primary Completion: 2018-04-02
• Study Completion: 2018-04-02
• Results First Submitted: 2020-05-20
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Results First Posted: 2020-07-27
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 198

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

    • 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

• • Known intolerance to statins

  • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Lifestyle counseling	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
Treatment	Metoprolol	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
Treatment	Atorvastatin	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
Treatment	Lisinopril	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

Primary Outcome Measures

Name	Time	Method
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism	30 days

Secondary Outcome Measures

Name	Time	Method
Modified Composite of Cardiovascular Events	30 days	the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation

Trial Locations

Locations (1)

NYU Hospital for Joint Diseases; 🇺🇸 New York, New York, United States