Pilot Study of Atorvastatin for Hip Fracture Patients (POST-OP Pilot)
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. 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 hip fracture patients is not known.
In this pilot study the investigators will treat 30 hip fracture patients with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug 1-2 days before 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 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Post-Operative Statin for Thromboprophylaxis & Cardiovascular Outcomes Protection (POST-OP) Pilot Trial|
- Percentage of patients with a peri-operative rise in high-sensitivity cardiac troponin I level [ Time Frame: Prior to surgery and post-operative day 2 ] [ Designated as safety issue: Yes ]We will measure high-sensitivity cardiac troponin I (hs-cTnI) at the time of recruitment pre-operatively and on post-operative day (POD) 2 in 30 hip fracture patients.
- Peri-operative rise in ROCK activity [ Time Frame: Prior to surgery and post-operative day 2 ] [ Designated as safety issue: No ]We will measure Rho-associated, coiled-coil containing protein kinase 1 (ROCK) activity in peripheral blood mononuclear cells isolated pre-operatively before statin administration, and on POD2 in 30 hip fracture patients randomized (1:1) to atorvastatin 40mg versus placebo.
- Peri-operative rise in interleukin (IL)-6 [ Time Frame: Prior to surgery and post-operative day 2 ] [ Designated as safety issue: No ]We will measure IL-6, high-sensitivity C-reactive protein (hs-CRP), and a panel of other cytokines pre-operatively before statin administration, and on POD 2 in 30 hip fracture patients randomized (1:1) to atorvastatin 40mg versus placebo.
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Atorvastatin 40mg daily starting at the time of recruitment, 1-2 days prior to hip fracture surgery, and continued until postoperative day 45.
Atorvastatin or placebo will be started within 1-2 hours of enrollment, at least 4 hours prior to hip fracture surgery, and continued nightly until postoperative day 45
Other Name: Lipitor
Placebo Comparator: Sugar pill
Sugar pill (placebo) daily starting at the time of recruitment, 1-2 days prior to hip fracture surgery, and continued until postoperative day 45.
- Thirty statin-naïve patients ≥ 65 years of age admitted to New York Presbyterian Hospital or Hospital for Special Surgery with an acute hip fracture surgery will be randomized in a 1:1 ratio to atorvastatin 40 mg daily or matching placebo.
- Atorvastatin will be initiated 1-2 days prior to surgery and will be continued until postoperative day (POD) 45.
- Patients will be assessed daily in the hospital for adverse events.
- Patients will be contacted by telephone weekly for four weeks after surgery and again on POD 45 and POD 90.
- Patients will mail back study medication bottles on POD 45 for pill counts to assess compliance.
- High sensitivity cardiac troponin I (hs-cTnI) will be measured pre-operatively (prior to atorvastatin therapy) and on POD 2.
- Rho-associated, coiled-coil containing protein kinase 1 (ROCK) activity in peripheral blood mononuclear cell will be measured preoperatively and on POD 2.
- Interleukin (IL)-6, high sensitivity C-reactive protein (hs-CRP), and a panel of other cytokines (IL-1β, IL-2, IL-2r, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, tumor necrosis factor (TNF)-α, interferon (IFN)-γ, and soluble (s)CD-40L) will be measured preoperatively and on POD 2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02197065
|Contact: Anne R Bass, MD||(212) email@example.com|
|Contact: Brian F Gage, MD MSc||(314) 454-8697||BGAGE@im.wustl.edu|
|United States, New York|
|New York Presbyterian Hospital (Cornell)||Not yet recruiting|
|New York, New York, United States, 10065|
|Hospital for Special Surgery||Not yet recruiting|
|New York, New York, United States, 10021|
|Principal Investigator:||Anne R Bass, MD||Hospital for Special Surgery, New York|