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

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ClinicalTrials.gov Identifier: NCT01086163
Recruitment Status : Unknown
Verified March 2010 by HeartDrug Research LLC.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2010
Last Update Posted : March 12, 2010
Sponsor:
Collaborator:
University of Oslo
Information provided by:
HeartDrug Research LLC

Tracking Information
First Submitted Date March 11, 2010
First Posted Date March 12, 2010
Last Update Posted Date March 12, 2010
Study Start Date October 2010
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 11, 2010)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
Official Title Effects of Prescription OMega-3 Fatty Acids (Omacor®, Lovaza®) on Platelet Activity in Patients With Coronary Artery Disease With Hypertriglyceridemia (OMPA-CAD)
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.
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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serial blood samples - at baseline, day 7, and day 14 after treatment assignment
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).
Condition Coronary Artery Disease
Intervention Drug: Omacor, omega-3 fatty acids in CAD patients
Omacor 1g versus 2g daily versus placebo
Other Name: Lovaza
Study Groups/Cohorts 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
Intervention: Drug: Omacor, omega-3 fatty acids in CAD patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 11, 2010)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01086163
Other Study ID Numbers HD-Oma-09/27D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Victor Serebruany. MD, PhD, HeartDrug Research laboratories
Study Sponsor HeartDrug Research LLC
Collaborators University of Oslo
Investigators
Study Chair: Alex Pokov, MD HeartDrug Research
PRS Account HeartDrug Research LLC
Verification Date March 2010