Fish Oil Versus Statins Versus Placebos in Reducing Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if Lipitor (atorvastatin) or fish oil supplements can help to control side effects of the heart that are commonly seen after lung surgery (such as irregular heartbeat). Researchers also want to learn if one of these drugs is more effective than the other at controlling side effects.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

1. Patients need to be in a normal sinus rhythm preoperatively.

2. Participants undergoing planned lobectomy and 60 years of age or older or participants undergoing planned pneumonectomy and 18 years of age or older.

3. Planned procedure is 5 days after the start of taking study drugs.

4. Signed written informed consent

5. Women of childbearing potential must have a negative pregnancy test (A woman of childbearing potential is a women who has not been naturally postmenopausal for at least 12 consecutive months or who has not undergone previous surgical sterilization)

6. Adequate liver function evidenced by; aspartate aminotransferase (AST or SGOT)* Upper Limits of Normal (ULN), and alanine aminotransferase (ALT or SGPT)ULN

Exclusion Criteria:

1. Any history of supraventricular arrhythmia for which the patient is taking medications.

2. Current use of antiarrhythmic medications other than beta-receptor antagonists, calcium-channel antagonists, or digitalis.

3. Use of any supplemental n-3 fatty acids during the previous three months.

4. Use of any statin therapy during the previous three months.

5. Patients known to have a history of recent drug or alcohol abuse.

6. Known allergy to seafood

7. Current use of Gemfibrozil and Fenofibrate.