Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thoracic Surgery
Intervention: Atorvastatin (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): David Amar, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
Summary
This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this
drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic
surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce
problems after surgery such as arrhythmias or lung inflammation which may be serious. This
study will be randomized and double blind, meaning that patients are placed in groups purely
by chance, like flipping a coin. Neither the patient or doctor will know which group the
patient is in.
Clinical Details
Official title: Double-Blind Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To determine whether one week of preventive therapy with atorvastatin (n=240) prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.
Secondary outcome: To determine whether one week of preventive therapy with atorvastatin (n=240) reduced the rate of pulmonary complications when compared to placebo and attenuated inflammatory and oxidative markers.
Detailed description:
Hypothesis: Statins attenuate perioperative inflammatory and oxidative mechanisms that
contribute to the initiation and severity of cardiopulmonary complications after thoracic
surgery.
Aim 1. To determine whether prophylactic administration of atorvastatin attenuates the
inflammatory and oxidative response to surgery and significantly reduces the composite risk
of cardiovascular morbidity (atrial fibrillation (AF), acute coronary syndrome, myocardial
infarction (MI), cerebrovascular accident (CVA), pulmonary embolism) and mortality within 30
days after thoracic surgery.
Aim 2. To explore whether prophylactic administration of atorvastatin attenuates the
inflammatory and oxidative (CRP, IL-6, TNF, and MPO) response to surgery and significantly
reduces the overall risk of pulmonary complications (atelectasis, pneumonia, pneumonitis,
acute respiratory failure) after thoracic surgery.
Aim 3. To explore the association of single nucleotide polymorphism (SNP) changes in genes
linked to atrial fibrillation and inflammatory markers and development of pulmonary
morbidity after thoracic surgery.
Aim 4. To explore whether an imbalance between metalloproteinase (MMP)-1 and its inhibitor
(TIMP) is associated with postoperative atrial fibrillation risk and/or development of
pulmonary morbidity after thoracic surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients ≥ 18 yr. scheduled for anatomic lung resection (segmentectomy,
lingulectomy, possible or definite lobectomy, bilobectomy, pneumonectomy or
extrapleural pneumonectomy) with or without chest wall resection or limited resection
- Patients with regular cardiac rhythm
- Patients able to take oral capsules
- Patients capable of providing written, informed consent
- Patients without known hepatic or kidney disease
Exclusion Criteria:
- Patients already taking any statin, gemfibrozil (Lopid), or ezetimibe (Zetia)
- Hypersensitivity to atorvastatin
- Chronic atrial fibrillation
- Patients already taking class Ic or III antiarrhythmic drugs
- Known pregnancy a urine pregnancy test will be given to women of childbearing age
- Known history of active hepatic disease or known hepatic insufficiency
- Known history of active kidney disease or insufficiency
Locations and Contacts
Memorial Sloan-Kettering Cancer Center 1275 York Avenue, New York, New York 10021, United States
Additional Information
Memorial Sloan-Kettering Cancer Center
Starting date: July 2006
Last updated: May 29, 2014
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