The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes
The Efficacy and Short-Term Safety of Docosahexaenoic Acid (DHA) and Statin Therapy for Subjects With Coronary Artery Disease or Cardiac Risk Equivalents With Moderate Hypertriglyceridemia (IIb)
1 other identifier
interventional
60
1 country
1
Brief Summary
This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin, etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease, stroke or diabetes). The rationale for the study is based around the finding that patients with CAD have an approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is one of the ingredients in fish oil). In studies of statin-based therapies, it has been observed that statins reduce the risk of coronary events 20-45%. There has not yet been research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in patient treatment either to reduce recurrent cardiac events or to address another reported finding of fish oils to lower triglyceride levels (triglyceride is a form of "blood fat"). This research project will be a pilot project to assess the safety and effectiveness of DHA "add-on" therapy in patients currently being treated with statins for CAD. The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower triglyceride levels in the blood. This is a double-blinded randomized clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 18, 2011
July 1, 2006
August 2, 2006
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lowering of triglyceride level
Secondary Outcomes (1)
Alteration of LDL particle size
Interventions
Eligibility Criteria
You may qualify if:
- CAD or Risk Equivalent
- On any statin therapy
- At NCEP LDL goal (\<100)
- TG\>200 mg%
You may not qualify if:
- TG\>500, TG levels that vary more than 25% during base-line
- Poorly controlled DM
- BMI\>40
- Use of fibrates, niacin, other fish oil product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maine Center for Lipids and Cardiovascular Health
Scarborough, Maine, 04074, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard M Keilson, MD, MPH
Maine Center for Lipids and Cardiovascular Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 4, 2006
Study Start
January 1, 2006
Study Completion
May 1, 2007
Last Updated
November 18, 2011
Record last verified: 2006-07