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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by HeartDrug Research LLC.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Oslo
Information provided by:
HeartDrug Research LLC
ClinicalTrials.gov Identifier:
NCT01086163
First received: March 11, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.

Condition Intervention
Coronary Artery Disease
Drug: Omacor, omega-3 fatty acids in CAD patients

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Prescription OMega-3 Fatty Acids (Omacor®, Lovaza®) on Platelet Activity in Patients With Coronary Artery Disease With Hypertriglyceridemia (OMPA-CAD)

Resource links provided by NLM:


Further study details as provided by HeartDrug Research LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serial blood samples - at baseline, day 7, and day 14 after treatment assignment


Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Lovaza

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.

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086163

Contacts
Contact: Ilya Pokov, BS 410-371-6204 pokov3@comcast.net
Contact: Serge Surigin, BS 443-824-2846 serge.surigin@gmail.com

Locations
United States, Maryland
Victor Serebruany Recruiting
Towson, Maryland, United States, 21204
Contact: Ilya Pokov, BS    410-371-6204    pokov3@comcast.net   
Sponsors and Collaborators
HeartDrug Research LLC
University of Oslo
Investigators
Study Chair: Alex Pokov, MD HeartDrug Research
  More Information

No publications provided

Responsible Party: Dr. Victor Serebruany. MD, PhD, HeartDrug Research laboratories
ClinicalTrials.gov Identifier: NCT01086163     History of Changes
Other Study ID Numbers: HD-Oma-09/27D
Study First Received: March 11, 2010
Last Updated: March 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by HeartDrug Research LLC:
Omacor
Simvastatin
Aspirin
Platelet activity
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypertriglyceridemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 14, 2014