Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00375518

Purpose

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.

Condition	Intervention
Thoracic Surgery	Drug: Atorvastatin Drug: Placebo

MedlinePlus related topics: Surgery

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Double-Blind Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: prior to surgery and one week 5 days)after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	276
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Atorvastatin	Drug: Atorvastatin Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
2: Placebo Comparator placebo	Drug: Placebo Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375518

Contacts

Contact: David Amar, MD	212-639-6798	amard@mskcc.org
Contact: Barnard Park, MD	212-639-8874	parkb@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue	Recruiting
New York, New York, United States, 10021
Contact: David Amar, MD 212-639-6798 amard@mskcc.org
Contact: Bernanrd Park, MD 212-639-8874 parkb@mskcc.org
Principal Investigator: David Amar, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

David Amar, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan Kettering Cancer Center ( David Amar, MD )
Study ID Numbers:	06-079
Study First Received:	September 11, 2006
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00375518 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Thoracic Surgery
Cardiopulmonary complications
Atorvastatin

Study placed in the following topic categories:

Antimetabolites
Antilipemic Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Atorvastatin

ClinicalTrials.gov processed this record on May 07, 2009