Lovaza's Effect on the Activation of Platelets

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to determine the effects of Lovaza in platelet function studies

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Invitrox
• Collaborator: Reliant Pharmaceuticals

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.