Pilot Study of Atorvastatin for Orthopedic Surgery Patients
Condition: Hip Fracture; Myocardial Ischemia; Inflammation
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Inflammation; Ischemia; Hip Fractures
Intervention: Atorvastatin; Placebo
Intervention description: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 65 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: hip fracture; myocardial ischemia; statin; surgery; troponin; complication; arthroplasty; hip; knee; orthopedic; atorvastatin; cardiovascular

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hip fracture or elective hip or knee arthroplasty

          -  Age 65 years or older

          -  Life expectancy > 3 months

        Exclusion Criteria:

          -  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