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

NCT01086163 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2010-03-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Omacor, omega-3 fatty acids in CAD patients

Omacor 1g versus 2g daily versus placebo

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER
  • HeartDrug Research LLC

    lead OTHER

Principal Investigators

  • Alex Pokov, MD · HeartDrug Research

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-02-28
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086163 on ClinicalTrials.gov