Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
OMPA-CAD
Effects of Prescription OMega-3 Fatty Acids (Omacor®, Lovaza®) on Platelet Activity in Patients With Coronary Artery Disease With Hypertriglyceridemia (OMPA-CAD)
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMarch 12, 2010
March 1, 2010
4 months
March 11, 2010
March 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (1)
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: * survived first-time AMI more than 12 months 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
Interventions
Omacor 1g versus 2g daily versus placebo
Eligibility Criteria
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).
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HeartDrug Research LLClead
- University of Oslocollaborator
Study Sites (1)
Victor Serebruany
Towson, Maryland, 21204, United States
Biospecimen
Serial blood samples - at baseline, day 7, and day 14 after treatment assignment
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alex Pokov, MD
HeartDrug Research
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 12, 2010
Study Start
October 1, 2010
Primary Completion
February 1, 2011
Study Completion
April 1, 2011
Last Updated
March 12, 2010
Record last verified: 2010-03