Hypertriglyceridemia (TG>200<500)NCT00360217
The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes
A study testing docosahexanoic acid (DHA) in people with Hypertriglyceridemia (TG>200<500) and Hyperlipidemia, run by Maine Center for Lipids and Cardiovascular Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypertriglyceridemia (TG>200<500), Hyperlipidemia, Coronary Artery Disease
- What is being tested?
- docosahexanoic acid (DHA)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAD or Risk Equivalent
- On any statin therapy
- At NCEP LDL goal (<100)
- TG>200 mg%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maine Center for Lipids and Cardiovascular Health
Scarborough, Maine, 04074
About this 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)
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.
Read the 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 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 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.
- This is a single-center, prospective, randomized, double-blinded, placebo-controlled, parallel-group clinical trial of Martek's DHASCO™ versus placebo in subjects with CAD or risk equivalents (including type II DM)
- There will be a 4-wk run-in period to assure both diet and triglyceride stabilization.
- 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
- Patients will be treated for an 8 week period. Visits will occur every other week during the treatment cycle.
- 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
- Conditions
- Hypertriglyceridemia (TG>200<500), Hyperlipidemia, Coronary Artery Disease, Coronary Risk Equivalent, Diabetes
- Being tested
- docosahexanoic acid (DHA)
- Keywords
- Omega-3, Triglyceride, Hyperlipidemia, Coronary Artery Disease, Fatty Acids, Safety, Fish Oil, Docosohexanoic Acid
- Medical subject headings
- Hypertriglyceridemia, Hyperlipidemias, Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docosahexanoic acid (DHA)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowering of triglyceride level
Secondary outcomes (1)
Alteration of LDL particle size
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startJan 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertriglyceridemia (TG>200<500)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maine Center for Lipids and Cardiovascular Health
- Sponsor type
- University, hospital or other
- Investigators
- Leonard M Keilson, MD, MPH, Principal investigator, Maine Center for Lipids and Cardiovascular Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360217
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2006
- First submitted
- 2 Aug 2006
- Last updated
- 18 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00360217
- Acronym / sponsor ID
- 1
- Conditions
- Hypertriglyceridemia (TG>200<500), Hyperlipidemia, Coronary Artery Disease, Coronary Risk Equivalent, Diabetes
- Keywords
- Omega-3, Triglyceride, Hyperlipidemia, Coronary Artery Disease, Fatty Acids, Safety, Fish Oil, Docosohexanoic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maine Center for Lipids and Cardiovascular HealthUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- May 2007 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 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.
- This is a single-center, prospective, randomized, double-blinded, placebo-controlled, parallel-group clinical trial of Martek's DHASCO™ versus placebo in subjects with CAD or risk equivalents (including type II DM)
- There will be a 4-wk run-in period to assure both diet and triglyceride stabilization.
- 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
- Patients will be treated for an 8 week period. Visits will occur every other week during the treatment cycle.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CAD or Risk Equivalent
- On any statin therapy
- At NCEP LDL goal (<100)
- TG>200 mg%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docosahexanoic acid (DHA) | Drug | – |
Primary outcome
Lowering of triglyceride level
1 secondary outcome
Alteration of LDL particle size
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard M Keilson, MD, MPH principal investigator
Maine Center for Lipids and Cardiovascular Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing docosahexanoic acid (DHA) in people with Hypertriglyceridemia (TG>200<500) and Hyperlipidemia, run by Maine Center for Lipids and Cardiovascular Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowering of triglyceride level. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2011.