DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017