Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia

• Status: Unknown status
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently approved by the Federal authorities for the drug management of post-infarction patients with high blood triglycerides. Given the growing length of CAD progression, it is pertinent that many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet properties of PO-3A will be a highly desirable and attractive commodity of this medication.

The investigators believe that Omacor®/Lovaza® is ideally positioned for the chronic management of CAD as a safe, efficient, and "gentle" agent with no harmful interactions with statins or aspirin.

The investigators hypothesize that addition of Omacor may add mild antiplatelet protection for CAD patients.

The study objectives are:

• To assess the ex vivo effects of Omacor® on platelet function in patients with coronary artery disease (CAD).

• To compare ex vivo platelet-related effects after 7 and 14 days of therapy with Omacor and statin combination versus statin alone in patients with chronic stable coronary heart disease.

• To establish the relation of changes in platelet activity (if any) with the lipid profile to prove an additional benefit of Omacor® on top of statin and aspirin.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HeartDrug Research LLC
• Collaborator: University of Oslo

Criteria

Inclusion Criteria:

• Stable documented coronary artery disease proven by angiography treated with statin and aspirin. In order to achieve homogeneity within this population, the following additional inclusion criteria will apply:

• survived first-time AMI more than 12 mths ago

• stable medical treatment during the last 3 months (except removal of Plavix)

• Ethnicity: Caucasians

• Males, 50 - 60 yrs

• Non-diabetics

• Excluded are those who eat more than one meal of fish / week

• Excluded are those who take omega-3 supplements of any sorts

Exclusion Criteria:

• Thrombolytic therapy or GP IIb/IIIa inhibitor within 30 days of enrollment

• Platelet count < 100,000

• History of bleeding disorder

• Hct < 30, serum creatinine ≥3 mg/dL, liver impairment defined as ALT/AST > 3 times upper limit of normal.

• Glomerular filtration rate <50ml/min

• Admission for acute vascular syndrome (unstable angina, MI, stroke), revascularization procedure with stent placement, or other major coronary/cerebrovascular event within 30 days.

• Active participation in other investigational drug or device trial within the last 30 days.

• Allergy or intolerance to any of the study medications.

• Antiplatelet agent other than aspirin or

• Insulin therapy

• Cancer of any localization