Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

Double-Blind Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375518
• Other study ID #: 06-079
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: May 2014

Study information

• Verified date: December 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Thoracic Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center 1275 York Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the Postoperative Complications Found in Each Group	To determine whether one week of preventive therapy with atorvastatin 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

External Links

•   Memorial Sloan-Kettering Cancer Center