Pilot Study of Atorvastatin for Orthopedic Surgery Patients
Information source: Hospital for Special Surgery, New York
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Fracture; Myocardial Ischemia; Inflammation
Intervention: Atorvastatin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hospital for Special Surgery, New York Official(s) and/or principal investigator(s): Anne R Bass, MD, Principal Investigator, Affiliation: Hospital for Special Surgery, New York
Overall contact: Anne R Bass, MD, Phone: (212) 774-7043, Email: bassa@hss.edu
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.
Clinical Details
Official title: The Post-Operative Statin for Thromboprophylaxis & Cardiovascular Outcomes Protection (POST-OP) Pilot Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Percentage of patients with a peri-operative rise in high-sensitivity cardiac troponin I level
Secondary outcome: Peri-operative rise in high sensitivity C-reactive protein (hs-CRP)
Detailed description:
- Thirty statin-naïve patients ≥ 65 years of age admitted to New York Presbyterian
Hospital or Hospital for Special Surgery with an acute hip fracture, or for elective
hip or knee arthroplasty will be randomized in a 1: 1 ratio to atorvastatin 40 mg daily
or matching placebo.
- Atorvastatin will be initiated at least 4 hours prior to hip fracture surgery, or 4
days prior to arthroplasty, 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.
- High sensitivity C-reactive protein (hs-CRP), and a panel of 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.
- Rho-associated, coiled-coil containing protein kinase 1 (ROCK) activity in peripheral
blood mononuclear cell will be measured preoperatively and on POD 2.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Anne R Bass, MD, Phone: (212) 774-7043, Email: bassa@hss.edu
Hospital for Special Surgery, New York, New York 10021, United States; Recruiting Fein Arielle, BA, Phone: 212-774-7043, Email: FeinA@hss.edu Anne R Bass, MD, Phone: 212-774-7043, Email: BassA@hss.edu
New York Presbyterian Hospital (Cornell), New York, New York 10065, United States; Recruiting Arielle Fein, BA, Phone: 212-774-7043, Email: FeinA@hss.edu Anne R Bass, MD, Phone: 2127747043, Email: BassA@hss.edu
Additional Information
Starting date: September 2014
Last updated: April 27, 2015
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