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

This study has been completed.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00976872
First received: September 13, 2009
Last updated: June 7, 2010
Last verified: September 2009
  Purpose

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 Intervention
Inflammation
Blood Pressure
Platelet Function
Endothelial Function
Drug: omega-3
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • augmentation index [ Time Frame: 0, 3 weeks, 6 weeks, 20 weeks ] [ Designated as safety issue: No ]
    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:
  • blood pressure (24 hours monitor) [ Time Frame: 0, or 3 weeks, 6 weeks, 20 weeks ] [ Designated as safety issue: No ]
    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.

  • platelet function [ Time Frame: 0, 3 weeks, 6 weeks, 20 weeks ] [ Designated as safety issue: No ]
    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.

  • Isoprostane [ Time Frame: 0, 3 weeks, 6 weeks, 20 weeks ] [ Designated as safety issue: No ]
    STAT-8-Isoprostane levels were assessed by a specific EIA kit (Cayman Chemicals, USA).

  • 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.


Enrollment: 52
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976872

Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Director: shai efrati asaf-harofe medical center
  More Information

No publications provided

Responsible Party: Dr. Keren Doenyas-barak, Assaf-HarofehMC
ClinicalTrials.gov Identifier: NCT00976872     History of Changes
Other Study ID Numbers: keren1
Study First Received: September 13, 2009
Last Updated: June 7, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
omega 3
inflammation
augmentation index
endothelial function

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014