The Post-Operative Statin for Thromboprophylaxis & Cardiovascular Outcomes Protection (POST-OP) Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip fracture or elective hip or knee arthroplasty
- •Age 65 years or older
- •Life expectancy > 3 months
排除标准
- •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
研究组 & 干预措施
Sugar pill
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
干预措施: Placebo (Drug)
Atorvastatin
Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)
时间窗: 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.
Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I
时间窗: 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
次要结局
- Peri-operative Rise in Interleukin-6 (IL-6) Levels(Change from preoperative to postoperative day 2)