Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
Status unconfirmed · Has a placebo group
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01086163
- Run by
- HeartDrug Research LLC
- People needed
- 30
- Starts
- 2010-10-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2010-03-12
Who can join
Age: 50 and older, up to 60. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Victor Serebruany — Towson, Maryland, United States
Full record on ClinicalTrials.gov
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