Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360217
Status:
COMPLETED
Last Update Posted:
2011-11-18
First Post:
2006-08-02
Brief Title:
The Triglyceride Lowering Effect of an Omega-3 Fat DHA in Addition to Statin Therapy for Patients With CAD or Diabetes
Sponsor:
Maine Center for Lipids and Cardiovascular Health
Organization:
Maine Center for Lipids and Cardiovascular Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 diseaseCADor 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 ie 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
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 ie 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
Detailed Description:
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 50000 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 strategy 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
1 This is a single-center prospective randomized double-blinded placebo-controlled parallel-group clinical trial of Marteks DHASCO versus placebo in subjects with CAD or risk equivalents including type II DM
2 There will be a 4-wk run-in period to assure both diet and triglyceride stabilization
3 After the base-line run-in period if triglyceride levels exceed 200 mg they will be eligible to procede with the intervention either placebo or 2 grams of DHA
4 Patients will be treated for an 8 week period Visits will occur every other week during the treatment cycle
5 Laboroatory parameters to be followed during the course of the clinical trial includes beta quantification of lipids NMR particle analysis of lipoprotein particle size apoprotein genotyping and other basic chemistry measurements
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 50000 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 strategy 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
1 This is a single-center prospective randomized double-blinded placebo-controlled parallel-group clinical trial of Marteks DHASCO versus placebo in subjects with CAD or risk equivalents including type II DM
2 There will be a 4-wk run-in period to assure both diet and triglyceride stabilization
3 After the base-line run-in period if triglyceride levels exceed 200 mg they will be eligible to procede with the intervention either placebo or 2 grams of DHA
4 Patients will be treated for an 8 week period Visits will occur every other week during the treatment cycle
5 Laboroatory parameters to be followed during the course of the clinical trial includes beta quantification of lipids NMR particle analysis of lipoprotein particle size apoprotein genotyping and other basic chemistry measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None