Risk Factor Control Before Orthopedic Surgery

Stopped early · Phase 4

Conditions studied: Osteoarthritis, Cardiovascular Disease

In brief

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

Key facts

Study ID

NCT01837069

Run by

NYU Langone Health

People needed

198

Starts

2014-02-01

Expected to finish

2018-04-02

Last updated by the study team

2020-07-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • ≥ 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

You may not qualify if…

• • 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

Where it is running

• NYU Hospital for Joint Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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