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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

Page last updated: August 23, 2015

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