Omega 3 Action on Cardiovascular Risk Factors in Patients Treated With Statins - Full Text View

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:

MedlinePlus related topics: Statins

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

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

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 May 23, 2013