Clinical trial NCT00515541 (phase 2, status: completed)
Conditions: cardiovascular disease, bleeding
ICD codes: A52.00, A52.09, A50.54, Z01.810, Q87.418, Z13.6, R94.30, N92.3, N95.0, K29.80, K29.81, I85.00, I85.01, K20.80
Drugs: lovaza
SMILES: CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O
Eligibility criteria:

        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 (< or =325 mg/day)or combination
             therapy with clopidogrel and aspirin (< or =325 mg/day).

          -  The subject must be able to read, understand, and sign an informed consent form and
             follow protocol.

          -  To be enrolled in the study, subjects must be clinically stable on stable medical
             therapy throughout the duration of the study and meet the following criteria:

          -  Healthy volunteers

          -  Volunteers with stable coronary artery disease are those with:

          -  Prior MI (>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 < 60 ml/min (MDRD)
             and/or a serum creatinine > 2.0 mg/dl.

          -  History of significant anemia, or baseline hemoglobin < 11.0 g/dl.

          -  Baseline PT>ULN, INR>1.3, and aPTT>ULN in subjects who are not on chronic warfarin
             therapy.

          -  History of thrombocytopenia, or baseline platelet count of < 100,000

          -  History of thrombocytosis, 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.