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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omacor dose titration | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacor, omega-3 fatty acids in CAD patients | Drug | Omacor 1g versus 2g daily versus placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in platelet aggregation after Lovaza® (1 or 2g/daily) in patients treated with aspirin + simvastatin versus those matched patients treated with placebo+aspirin +simvastatin in combination. | Day 7 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in expression of P-selectin and PAR-1 receptors after treatment with Lovaza® (1 or 2g/daily) in patients treated with aspirin + simvastatin versus those matched patients treated with placebo+aspirin +simvastatin in combination. | Day 7 and Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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Serial assessments of platelet characteristics from 10 patients in each of the 3 study groups at 2 time points for the total of 60 platelet samples. First, patients with stable coronary disease will be identified, telephone interviews will be conducted, and screening visits scheduled to those who qualify. We expect to triage 50 patients who then will be examined, and biochemistry markers tested. Patients will be allocated to one of three treatment arms based on randomization. Enrollment will continue until all 3 cells will be filled (n=10 each).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilya Pokov, BS | Contact | 410-371-6204 | pokov3@comcast.net | |
| Serge Surigin, BS | Contact | 443-824-2846 | serge.surigin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alex Pokov, MD | HeartDrug Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victor Serebruany | Towson | Maryland | 21204 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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Serial blood samples - at baseline, day 7, and day 14 after treatment assignment
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |