Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Metabolic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 50 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | October 2010 |
| End Date: | April 2011 |
| Contact: | Ilya Pokov, BS |
| Email: | pokov3@comcast.net |
| Phone: | 410-371-6204 |
Effects of Prescription OMega-3 Fatty Acids (Omacor®, Lovaza®) on Platelet Activity in Patients With Coronary Artery Disease With Hypertriglyceridemia (OMPA-CAD)
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.
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.
In terms of incidence, prevalence, morbidity, and economic costs, coronary artery disease
represents a number 1 public health concern. 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. Despite significant
progress in the prevention and treatment of vascular disease in the Western World in the
past two decades, national statistics indicate that the incidence and prevalence of heart
disease has been increasing steadily. 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.
We 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.
Also considering low clinical incidence of aspirin-induced interactions with other classes
of drugs, Lovaza® may fit nicely into a standard cocktail for diabetes, hypertension,
depression, arrhythmias, and heart failure management of CAD patients, which will expand the
drug utilization. However, platelet-related effects of Lovaza® on top of aspirin and statin
in patients with stable coronary disease are not known, but may be important due to the high
incidence of aspirin resistance and heavy burden of thrombin activation in such patients. We
have a large pool of patients with documented CAD (300-350/annum), and we will be able to
enroll relatively large amount of quality patients fast.
represents a number 1 public health concern. 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. Despite significant
progress in the prevention and treatment of vascular disease in the Western World in the
past two decades, national statistics indicate that the incidence and prevalence of heart
disease has been increasing steadily. 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.
We 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.
Also considering low clinical incidence of aspirin-induced interactions with other classes
of drugs, Lovaza® may fit nicely into a standard cocktail for diabetes, hypertension,
depression, arrhythmias, and heart failure management of CAD patients, which will expand the
drug utilization. However, platelet-related effects of Lovaza® on top of aspirin and statin
in patients with stable coronary disease are not known, but may be important due to the high
incidence of aspirin resistance and heavy burden of thrombin activation in such patients. We
have a large pool of patients with documented CAD (300-350/annum), and we will be able to
enroll relatively large amount of quality patients fast.
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
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