ID
36487
Beschrijving
Pilot Study of Atorvastatin for Orthopedic Surgery Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02197065 Brief 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.
Link
https://clinicaltrials.gov/show/NCT02197065
Trefwoorden
Versies (1)
- 17.05.19 17.05.19 -
Houder van rechten
Hospital for Special Surgery, New York
Geüploaded op
17. Mai 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Atorvastatin as Post-OP NCT02197065
Eligibility Criteria
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beschrijving
Pathological Hip fracture (cancer)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C0016663
- UMLS CUI [1,3]
- C0678226
- UMLS CUI [1,4]
- C0006826
Beschrijving
Recent Statin Use
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0360714
- UMLS CUI [1,3]
- C0332185
Beschrijving
Statin intolerance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0360714
Beschrijving
Myocardial infarction or unstable angina
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155626
- UMLS CUI [2]
- C0002965
Beschrijving
Cardial Handicap
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027051
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0948089
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0002962
- UMLS CUI [4,1]
- C0262926
- UMLS CUI [4,2]
- C0027056
Beschrijving
Hip fracture with peripheral artery disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C1704436
Beschrijving
Hip fracture with cerebral insult
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019557
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C0007787
- UMLS CUI [2,1]
- C0019557
- UMLS CUI [2,2]
- C0262926
- UMLS CUI [2,3]
- C0038454
Beschrijving
Muscle Disorder
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0026845
- UMLS CUI [1,2]
- C0012634
Beschrijving
Liver Disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0205404
- UMLS CUI [2,1]
- C0151905
- UMLS CUI [2,2]
- C0205250
Beschrijving
Renal disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022658
- UMLS CUI [1,2]
- C0205404
- UMLS CUI [2]
- C0151577
Beschrijving
HIV Protease Inhibitor or Hepatitis C Protease Inhibitor
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0162714
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0019196
- UMLS CUI [2,3]
- C0033607
Beschrijving
Antimicrobial therapy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0014806
- UMLS CUI [2]
- C0055856
- UMLS CUI [3]
- C0027996
- UMLS CUI [4]
- C0360363
Beschrijving
Pregant or Breastfeeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
- UMLS CUI [3]
- C0032992
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Eligibility Criteria
- StudyEvent: Eligibility
C0392806 (UMLS CUI [2])
C0086511 (UMLS CUI [3])
C0016663 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0360714 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
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C0205404 (UMLS CUI [1,2])
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C0151577 (UMLS CUI [2])
C0162714 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0033607 (UMLS CUI [2,3])
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C0360363 (UMLS CUI [4])
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