Double-Blind Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
Hypothesis: Statins attenuate perioperative inflammatory and oxidative mechanisms that
contribute to the initiation and severity of cardiopulmonary complications after thoracic
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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.
one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery
David Amar, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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