Pilot Study of Atorvastatin for Orthopedic Surgery Patients
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborators:
University of Utah Washington University School of Medicine Weill Medical College of Cornell University