Double-Blind Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
18 Years
N/A
Both
Thoracic Surgery
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery
Safety Issue:
Yes
Principal Investigator
David Amar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
06-079
NCT ID:
NCT00375518
Start Date:
July 2006
Completion Date:
July 2013
Related Keywords:
- Thoracic Surgery
- Thoracic Surgery
- Cardiopulmonary complications
- Atorvastatin
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | New York, New York 10021 |
