COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Omega 3 Action on Cardiovascular Risk Factors in Patients Treated With Statins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976872
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : June 8, 2010
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

Recent evidences showed beneficial effects of omega-3 fatty acids on cardiovascular morbidity and mortality.

Regular Omega-3 fatty acid consumption reduces cardiovascular mortality, ischemic heart disease and stroke mortality. There is probably no single mechanism of action that explains this beneficial effect; but possible mechanisms include reduce susceptibility of the heart to ventricular arrhythmia, antithrombogenic effect, reduce triglyceride level, promotion of nitric oxide-induced endothelial relaxation, and retard growth of atherosclerotic plaque.

The combination of satins and omega3 was proved to be better the any of the drugs alone in several studies.

The purpose of the study is to investigate several possible mechanisms that may explain the add on beneficial effect of omega-3 in hypercholesterolemic patients already treated with satins.

Condition or disease Intervention/treatment Phase
Inflammation Blood Pressure Platelet Function Endothelial Function Drug: omega-3 Drug: placebo Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supplementation of Omega-3 Fatty Acid Complex to Routine Statin Treatment Decreases Patients' Day-time Blood Pressure, Improves Inflammatory Status and Prohibits Platelet Aggregation
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: omega-3
omega-3: 2 pills of Omega"950"®, Solgar, New Jersey, USA. Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA
Drug: omega-3
omega-3: 2 pills of Omega"950"®, Solgar, New Jersey, USA. Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA

Placebo Comparator: placebo
hard gelatin capsule of Capsugel®, France, filled with 1ml of soya oil
Drug: placebo
hard gelatin capsule of Capsugel®, France, filled with 1ml of soya oil

Primary Outcome Measures :
  1. augmentation index [ Time Frame: 0, 3 weeks, 6 weeks, 20 weeks ]
    Each patient was seated in a quiet room, blood pressure was measured. Radial artery pressure waveform was sampled with a Millar tonometer (SPC-301, Millar Instruments) and calibrated to the average blood pressure. Waveforms were then processed using the specific software (SphygmoCor, version 7, AtCor). Integral system software was used for calculation of the averaged radial artery waveform and derivation of the corresponding central aortic pressure waveform, using a previously validated generalized transfer function.

Secondary Outcome Measures :
  1. blood pressure (24 hours monitor) [ Time Frame: 0, or 3 weeks, 6 weeks, 20 weeks ]
    Twenty-four-hour - ambulatory blood pressure monitoring was performed using the SpacelabsTM 90207 ambulatory blood pressure monitor (ABPM). The monitor was mounted on the non-dominant arm in the morning (8:00 AM to 10:00 AM) and removed following 24h. The recordings were registered every 20 minutes between 6:00 AM and midnight, and every 30 minutes between midnight and 6:00 AM. Based on these measurements, the mean values and the loads of blood pressure were calculated.

  2. platelet function [ Time Frame: 0, 3 weeks, 6 weeks, 20 weeks ]
    CPA method was applied for analyzing the capacity of platelets to aggregate and adhere in whole blood under flow conditions. In brief, 200 µL of citrated blood was placed into polystyrene wells and subjected to circulation at a high shear rate (1875 s-1) for 2 minutes with a rotating Teflon cone. The wells were then rinsed with water, stained by May-Grünwald dye and analyzed under inverted light microscope connected to an image analysis system.The results were expressed as percentages of the well surface covered by platelets and as the average size of the stained objects.

  3. Isoprostane [ Time Frame: 0, 3 weeks, 6 weeks, 20 weeks ]
    STAT-8-Isoprostane levels were assessed by a specific EIA kit (Cayman Chemicals, USA).

  4. PAI-1, TNF-alpha, IL6 [ Time Frame: 0, 3,6 and 20 weeks ]
    PAI-1, TNF-alpha and IL-6 were also measured by specific ELISAs (R &D, USA), according to the manufacturers' instructions.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • dyslipidemia controlled (LDL < 130)
  • statin treatment
  • triglycerides < 200
  • informed consent

Exclusion Criteria:

  • thrombocytopenia or bleeding tendency
  • uncontrolled diabetes mellitus
  • uncontrolled hypertension (systolic > 160 or diastolic > 100)
  • omega 3 pretreatment
  • recent acute coronary syndrome or cerebrovascular event (less than 3 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00976872

Sponsors and Collaborators
Assaf-Harofeh Medical Center
Layout table for investigator information
Study Director: shai efrati asaf-harofe medical center
Layout table for additonal information
Responsible Party: Dr. Keren Doenyas-barak, Assaf-HarofehMC Identifier: NCT00976872    
Other Study ID Numbers: keren1
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: September 2009
Keywords provided by Assaf-Harofeh Medical Center:
omega 3
augmentation index
endothelial function
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes