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

March 11, 2010 updated by: HeartDrug Research LLC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21204
        • Victor Serebruany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Omacor, omega-3 fatty acids in CAD patients
Omacor 1g versus 2g daily versus placebo
Other Names:
  • Lovaza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Day 7 and Day 14
Day 7 and Day 14

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Day 7 and Day 14
Day 7 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HeartDrug Research LLC

Collaborators

University of Oslo

Investigators

  • Study Chair: Alex Pokov, MD, HeartDrug Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 12, 2010

Last Update Submitted That Met QC Criteria

March 11, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-Oma-09/27D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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