Pilot Study of Atorvastatin for Orthopedic Surgery Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Hip Fracture, Myocardial Ischemia, Inflammation

In brief

Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Patients who have these complications have higher levels of inflammation postoperatively. Statins (such as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects are important in preventing heart attacks. Statins have been shown to reduce the risk of heart attacks in non-surgical patients, and to protect from heart attacks in patients having heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known. In this pilot study the investigators will treat 30 orthopedic surgery patients (hip fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug prior to surgery and take it for 45 days after surgery. Neither the doctors nor the patients will know whether they are taking atorvastatin or placebo. The investigators will look for evidence of inflammation and heart injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree of postoperative inflammation found in these patients. In this study, the investigators will use a very sensitive test of heart injury that can detect problems even when patients have no symptoms. The investigators hypothesize that this test will demonstrate silent heart injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study. The results of this trial will help us to develop a larger study in 1000 hip fracture and joint replacement patients to determine whether atorvastatin protects orthopedic surgery patients from heart injury and other complications of surgery.

Key facts

Study ID

NCT02197065

Run by

Hospital for Special Surgery, New York

People needed

20

Starts

2014-09-01

Expected to finish

2017-01-01

Last updated by the study team

2017-07-02

Who can join

Age: 65 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hip fracture or elective hip or knee arthroplasty
• Age 65 years or older
• Life expectancy > 3 months

You may not qualify if…

• Pathological hip fracture due to cancer
• Currently taking a statin, or took a statin within the last 30 days
• Previous statin intolerance
• Acute myocardial infarction or unstable angina
• History of myocardial infarction, acute coronary syndrome, angina, coronary/arterial re-vascularization
• Hip fracture patients with peripheral arterial disease
• Hip fracture patients with history of stroke or transient ischemic attack.
• Muscle disorder
• Serious liver disease or alanine aminotransferase > 3x upper limit of normal
• Serious renal disease (creatinine clearance <30cc/min)
• Treatment with HIV protease inhibitor or Hepatitis C protease inhibitor
• Treatment with erythromycin, clarithromycin, niacin or azole antifungal agent
• Pregnant, planning to become pregnant, or breastfeeding

Where it is running

• Hospital for Special Surgery — New York, New York, United States
• New York Presbyterian Hospital (Cornell) — New York, New York, United States

Full record on ClinicalTrials.gov

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