Risk Factor Control Before Orthopedic Surgery

• Status: Terminated
• Trial end date: 2018-04-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Atorvastatin; Atorvastatin Calcium; Lisinopril; Metoprolol

Criteria

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