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NCT Number: NCT02197065

Pilot Study of Atorvastatin for Orthopedic Surgery Patients

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.

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Key information

Conditions

Hip Fracture Cardiovascular Diseases Femoral Fractures Fractures, Bone Heart Diseases Hip Fractures Hip Injuries Inflammation Leg Injuries Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Wounds and Injuries

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital for Special Surgery, New York, United States

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45

Other names: Lipitor

Placebo

Drug

Primary outcomes

  1. Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I

    Time frame: change from preoperative to postoperative day 2

    The percentage of orthopedic patients with a ≥ 10 pg/mL rise in high-sensitivity cardiac troponin I (hs-cTnI) from baseline pre-operatively to post-operative day (POD)2

  2. Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Change from preoperative to post-operative day 2

    The change in the level of hs-CRP from baseline to POD2 in 20 orthopedic patients randomized (1:1) to atorvastatin 40mg versus placebo.

Secondary outcomes

  1. Peri-operative Rise in Interleukin-6 (IL-6) Levels

    Time frame: Change from preoperative to postoperative day 2

    The change in the level of IL-6 from baseline to POD2 in 16 arthroplasty patients randomized (1:1) to atorvastatin 40mg versus placebo.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • University of Utah
  • Washington University School of Medicine
  • Weill Medical College of Cornell University

Registry information

Official study title

The Post-Operative Statin for Thromboprophylaxis & Cardiovascular Outcomes Protection (POST-OP) Pilot Trial

Acronym: POST-OP Pilot

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 22, 2014
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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