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Sponsored by: |
Maine Center for Lipids and Cardiovascular Health |
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Information provided by: | Maine Center for Lipids and Cardiovascular Health |
ClinicalTrials.gov Identifier: | NCT00360217 |
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.
Condition | Intervention |
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Hypertriglyceridemia (TG>200<500) Hyperlipidemia Coronary Artery Disease Coronary Risk Equivalent Diabetes |
Drug: docosahexanoic acid (DHA) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 60 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2007 |
Omega-3 fatty acids (nPUFAs) have been embraced by Expert Panels and Guideline Committees of the American Heart Association as a result of randomized trials documenting reductions in cardiovascular events in patients with coronary artery disease. The antiarrhythmic effect or a modification in the atherogenicity of lipoprotein particles by nPUFA treatment are speculated mechanisms of action. Although precise bioactivity is not clear, nPUFAs have been demonstrated to lower triglyceride (TG) levels. TG reductions have also been demonstrated in three randomized clinical trials where nPUFAs in the form of fish oil containing both eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA) have been added to ongoing statin therapy.
There are at least 8 large randomized clinical trials that have utilized statin agents as monotherapy to reduce cardiovascular events in patients with CAD. These trials have included more than 50,000 patients. The National Cholesterol Education Program (NCEP) recently released a “white paper” further reducing the LDL treatment target to 70 mg% as a result of four recently published trials. Although cardiovascular events rate and mortality reduction of 20-30% have been described, there is still a sizable number of patients experiencing untoward outcomes in spite of ongoing statin therapy. A variety of mechanisms of disease progression have been speculated including ongoing inflammation, insulin resistance and specific species of lipoprotein particles including HDL and LDL sub-classes. There has been recognition by the NCEP that beyond the treatment with statin therapies less tested methods of therapy might need to be applied. These therapies have included the lowering of triglycerides.
It is the purpose of this pilot study to explore the relationship of DHA as a vehicle for triglyceride lowering in CAD patients receiving on-going statin therapy and candidates for the yet (untested) recommendation by NCEP of the need to lower triglyceride levels exceeding 200 mg% in statin-treated individuals.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barb Perry, FNP | 207 885 8777 | perryb@mmc.org |
United States, Maine | |
Maine Center for Lipids and Cardiovascular Health | Recruiting |
Scarborough, Maine, United States, 04074 | |
Contact: Barbara Perry, FNP 207-885-8777 perryb@mmc.org | |
Principal Investigator: Leonard M Keilson, MD, MPH | |
Sub-Investigator: David Keller, DO |
Principal Investigator: | Leonard M Keilson, MD, MPH | Maine Center for Lipids and Cardiovascular Health |
Study ID Numbers: | 1 |
Study First Received: | August 2, 2006 |
Last Updated: | August 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00360217 |
Health Authority: | United States: Institutional Review Board |
Omega-3 Triglyceride Hyperlipidemia Coronary Artery Disease |
Fatty Acids Safety Fish Oil Docosohexanoic Acid |
Arterial Occlusive Diseases Hyperlipidemias Hypertriglyceridemia Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Ischemia Arteriosclerosis Coronary Disease Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias Coronary Artery Disease Lipid Metabolism Disorders |
Cardiovascular Diseases |