Lovaza's Effect on the Activation of Platelets

Inclusion Criteria

• Males or females older than 18 years old who are able to ingest omega n3 fatty acids are eligible for this trial and are:
• On no antiplatelet and anticoagulation therapy, OR
• On chronic therapy with warfarin or aspirin alone ( 1 month) OR
• Prior revascularization: angioplasty ± stenting (> 1 month) OR
• Coronary artery bypass grafting (>3 months) OR
• Documented disease on coronary angiography.
• No planned no planned procedures or changes in medical therapies over the 24-week duration of the study
• Volunteers with stable atrial fibrillation are those with:
• Rate-controlled or paroxysmal atrial fibrillation on stable antiarrhythmic therapy.
• On a stable dose of warfarin and regular follow-up in an anticoagulation ("coumadin") clinic.
• No planned changes in antiarrhythmic therapies or cardioversion during the duration of the study.
• No recent admissions for atrial fibrillation (> 3 months)
• Subjects may not ingest other drugs known to cause a significant platelet abnormality while participating in this trial. (See list of prohibited medications, as outlined in Section 9)
• Patients must be assessable to the investigator for scheduled clinic visits during the duration of the trial.
• All female subjects of child bearing potential must have a negative serum pregnancy test prior to randomization and not plan on getting pregnant for the duration of the study.

Exclusion Criteria

• Any medical condition that would preclude ingestion of omega n3 fatty acids (Lovaza®).
• Subjects taking nutritional supplements of fish oil or flaxseed oil. These patients may become eligible if they are willing to discontinue these nutritional supplements for a 2-week washout period.
• Any other medical condition that would adversely affect the study objectives.
• Chronic medical conditions known to be associated with abnormal platelet function including:
• Liver dysfunction including abnormal liver function tests (AST, ALT, or alkaline phosphatase > upper limit of normal), known cirrhosis or chronic hepatitis.
• Chronic kidney disease with a calculated creatinine clearance 2.0 mg/dl.
• History of significant anemia, or baseline hemoglobin ULN, INR>1.3, and aPTT>ULN in subjects who are not on chronic warfarin therapy.
• History of thrombocytopenia, or baseline platelet count of 600,000
• Known bleeding diathesis and/or congenital hemostasis disorder and/or congenital platelet abnormalities.
• Any history of stroke in the past 12 months.
• History of peptic ulcer disease in the past year or gastrointestinal bleeding in the last 3 months.
• Genitourinary bleeding in the last 3 months.
• HIV or other infectious diseases that would expose laboratory personnel to unacceptable risks.
• Treatment within 30 days with an antiplatelet agent other than aspirin or clopidogrel such as eptifibatide, tirofiban or abciximab.
• Treatment within the past 7 days with unfractionated or low-molecular- weight heparin.
• Allergy to iodine, fish, or other components of the study drug.
• Alcohol or substance abuse.
• Emotionally or psychiatrically unstable.
• Use of any investigational drug or device within the past 30 days
• Any other factor that the investigator feels would put the patient at increased risk if participating in the study.
• Any Terminal illness or illness that may cause mortality that could obscure the results of the test in any way for them to appear inaccurate.