Pilot Study of Atorvastatin for Orthopedic Surgery Patients
| Status: | Completed |
|---|---|
| Conditions: | Angina, Peripheral Vascular Disease, Cardiology, Orthopedic, Orthopedic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 65 - 99 |
| Updated: | 3/2/2017 |
| Start Date: | September 2014 |
| End Date: | July 2016 |
The Post-Operative Statin for Thromboprophylaxis & Cardiovascular Outcomes Protection (POST-OP) Pilot Trial
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.
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.
- 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.
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.
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
We found this trial at
2
sites
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535 E 70th St
New York, New York 10021
New York, New York 10021
(212) 606-1000
Phone: 212-774-7043
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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