Status:
TERMINATED
Fish Oil Versus Statins Versus Placebos in Reducing Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
The Study Drugs: Atorvastatin is designed to lower cholesterol by blocking its production in the liver. This may help to decrease the chances of having a heart attack or a stroke. Fish oil supplemen...
Eligibility Criteria
Inclusion
- Patients need to be in a normal sinus rhythm preoperatively.
- Participants undergoing planned lobectomy and 60 years of age or older or participants undergoing planned pneumonectomy and 18 years of age or older.
- Planned procedure is 5 days after the start of taking study drugs.
- Signed written informed consent
- 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)
- Adequate liver function evidenced by; aspartate aminotransferase (AST or SGOT) \</= 2.5 \* Upper Limits of Normal (ULN), and alanine aminotransferase (ALT or SGPT) \</= 2.5 \* ULN
Exclusion
- Any history of supraventricular arrhythmia for which the patient is taking medications.
- Current use of antiarrhythmic medications other than beta-receptor antagonists, calcium-channel antagonists, or digitalis.
- Use of any supplemental n-3 fatty acids during the previous three months.
- Use of any statin therapy during the previous three months.
- Patients known to have a history of recent drug or alcohol abuse.
- Known allergy to seafood
- Current use of Gemfibrozil and Fenofibrate.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01259284
Start Date
January 1 2011
End Date
September 1 2011
Last Update
August 7 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030