Coronary Artery DiseaseOMPA-CADNCT01086163
Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
An observational study of Coronary Artery Disease, run by HeartDrug Research LLC at 1 site in United States.
Trial summary
Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently approved by the Federal authorities for the drug management of post-infarction patients with high blood triglycerides. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Omacor, omega-3 fatty acids in CAD patients
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2011
- Phase
- Observational
- 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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Serial assessments of platelet characteristics from 10 patients in each of the 3 study groups at 2 time points for the total of 60 platelet samples. First, patients with stable coronary disease will be identified, telephone interviews will be conducted, and screening visits scheduled to those who qualify. We expect to triage 50 patients who then will be examined, and biochemistry markers tested. Patients will be allocated to one of three treatment arms based on randomization. Enrollment will continue until all 3 cells will be filled (n=10 each).
Who may be able to join
- Stable documented coronary artery disease proven by angiography treated with statin and aspirin. In order to achieve homogeneity within this population, the following additional inclusion criteria will apply:
- survived first-time AMI more than 12 mths ago
- stable medical treatment during the last 3 months (except removal of Plavix)
- Ethnicity: Caucasians
- Males, 50 - 60 yrs
- Non-diabetics
- Excluded are those who eat more than one meal of fish / week
- Excluded are those who take omega-3 supplements of any sorts
Who cannot join
- Thrombolytic therapy or GP IIb/IIIa inhibitor within 30 days of enrollment
- Platelet count < 100,000
- History of bleeding disorder
- Hct < 30, serum creatinine ≥3 mg/dL, liver impairment defined as ALT/AST > 3 times upper limit of normal.
- Glomerular filtration rate <50ml/min
- Admission for acute vascular syndrome (unstable angina, MI, stroke), revascularization procedure with stent placement, or other major coronary/cerebrovascular event within 30 days.
Show all 11Show fewer
- Active participation in other investigational drug or device trial within the last 30 days.
- Allergy or intolerance to any of the study medications.
- Antiplatelet agent other than aspirin or
- Insulin therapy
- Cancer of any localization
Trial locations and contacts
1 site in 1 country.
United States1 site
Victor Serebruany
Towson, Maryland, 21204
Ilya Pokov, BS, 410-371-6204, pokov3@comcast.net
About this study
Official title: Effects of Prescription OMega-3 Fatty Acids (Omacor®, Lovaza®) on Platelet Activity in Patients With Coronary Artery Disease With Hypertriglyceridemia (OMPA-CAD)
Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently approved by the Federal authorities for the drug management of post-infarction patients with high blood triglycerides. Given the growing length of CAD progression, it is pertinent that many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet properties of PO-3A will be a highly desirable and attractive commodity of this medication.
The investigators believe that Omacor®/Lovaza® is ideally positioned for the chronic management of CAD as a safe, efficient, and "gentle" agent with no harmful interactions with statins or aspirin.
Read more
The investigators hypothesize that addition of Omacor may add mild antiplatelet protection for CAD patients.
The study objectives are:
- To assess the ex vivo effects of Omacor® on platelet function in patients with coronary artery disease (CAD).
- To compare ex vivo platelet-related effects after 7 and 14 days of therapy with Omacor and statin combination versus statin alone in patients with chronic stable coronary heart disease.
- To establish the relation of changes in platelet activity (if any) with the lipid profile to prove an additional benefit of Omacor® on top of statin and aspirin.
Read the detailed description
In terms of incidence, prevalence, morbidity, and economic costs, coronary artery disease represents a number 1 public health concern. Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently approved by the Federal authorities for the drug management of post-infarction patients with high blood triglycerides. Despite significant progress in the prevention and treatment of vascular disease in the Western World in the past two decades, national statistics indicate that the incidence and prevalence of heart disease has been increasing steadily. Given the growing length of CAD progression, it is pertinent that many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet properties of PO-3A will be a highly desirable and attractive commodity of this medication.
We believe that Omacor®/Lovaza® is ideally positioned for the chronic management of CAD as a safe, efficient, and "gentle" agent with no harmful interactions with statins or aspirin. Also considering low clinical incidence of aspirin-induced interactions with other classes of drugs, Lovaza® may fit nicely into a standard cocktail for diabetes, hypertension, depression, arrhythmias, and heart failure management of CAD patients, which will expand the drug utilization. However, platelet-related effects of Lovaza® on top of aspirin and statin in patients with stable coronary disease are not known, but may be important due to the high incidence of aspirin resistance and heavy burden of thrombin activation in such patients. We have a large pool of patients with documented CAD (300-350/annum), and we will be able to enroll relatively large amount of quality patients fast.
- Conditions
- Coronary Artery Disease
- Being tested
- Omacor, omega-3 fatty acids in CAD patients
- Keywords
- Omacor, Simvastatin, Aspirin, Platelet activity, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omacor, omega-3 fatty acids in CAD patientsDrug
Also called Lovaza
Omacor 1g versus 2g daily versus placebo
| Study group | Role | What they receive |
|---|---|---|
| Omacor dose titration | Stable documented coronary artery disease proven by angiography treated with statin and aspirin. In order to achieve homogeneity within this population, the following additional inclusion criteria will apply:
* survived first-time AMI more than 12 months ago
* stable medical treatment during the last 3 months (except removal of Plavix)
* Ethnicity: Caucasians
* Males, 50 - 60 yrs
* non-diabetics
* excluded are those who eat more than one meal of fish / week
* excluded are those who take omega-3 supplements of any sorts Receives: Drug: Omacor, omega-3 fatty acids in CAD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet aggregation after Lovaza® (1 or 2g/daily) in patients treated with aspirin + simvastatin versus those matched patients treated with placebo+aspirin +simvastatin in combination.
Measured: Day 7 and Day 14
Secondary outcomes (1)
Differences in expression of P-selectin and PAR-1 receptors after treatment with Lovaza® (1 or 2g/daily) in patients treated with aspirin + simvastatin versus those matched patients treated with placebo+aspirin +simvastatin in combination.
Measured: Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartDrug Research LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Alex Pokov, MD, Study chair, HeartDrug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086163
- Sponsor's protocol ID
- HD-Oma-09/27D
- Acronym
- OMPA-CAD
- Status last verified
- Mar 2010
- First submitted
- 11 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prescription OMega-3 Fatty Acids (Omacor®, Lovaza®) on Platelet Activity in Patients With Coronary Artery Disease With Hypertriglyceridemia (OMPA-CAD)
- ClinicalTrials.gov ID
- NCT01086163
- Acronym / sponsor ID
- OMPA-CAD / HD-Oma-09/27D
- Conditions
- Coronary Artery Disease
- Keywords
- Omacor, Simvastatin, Aspirin, Platelet activity, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HeartDrug Research LLCUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 12 Mar 2010 (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.
Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently approved by the Federal authorities for the drug management of post-infarction patients with high blood triglycerides. Given the growing length of CAD progression, it is pertinent that many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet properties of PO-3A will be a highly desirable and attractive commodity of this medication.
The investigators believe that Omacor®/Lovaza® is ideally positioned for the chronic management of CAD as a safe, efficient, and "gentle" agent with no harmful interactions with statins or aspirin.
The investigators hypothesize that addition of Omacor may add mild antiplatelet protection for CAD patients.
The study objectives are:
- To assess the ex vivo effects of Omacor® on platelet function in patients with coronary artery disease (CAD).
- To compare ex vivo platelet-related effects after 7 and 14 days of therapy with Omacor and statin combination versus statin alone in patients with chronic stable coronary heart disease.
- To establish the relation of changes in platelet activity (if any) with the lipid profile to prove an additional benefit of Omacor® on top of statin and aspirin.
Detailed description
In terms of incidence, prevalence, morbidity, and economic costs, coronary artery disease represents a number 1 public health concern. Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently approved by the Federal authorities for the drug management of post-infarction patients with high blood triglycerides. Despite significant progress in the prevention and treatment of vascular disease in the Western World in the past two decades, national statistics indicate that the incidence and prevalence of heart disease has been increasing steadily. Given the growing length of CAD progression, it is pertinent that many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet properties of PO-3A will be a highly desirable and attractive commodity of this medication.
We believe that Omacor®/Lovaza® is ideally positioned for the chronic management of CAD as a safe, efficient, and "gentle" agent with no harmful interactions with statins or aspirin. Also considering low clinical incidence of aspirin-induced interactions with other classes of drugs, Lovaza® may fit nicely into a standard cocktail for diabetes, hypertension, depression, arrhythmias, and heart failure management of CAD patients, which will expand the drug utilization. However, platelet-related effects of Lovaza® on top of aspirin and statin in patients with stable coronary disease are not known, but may be important due to the high incidence of aspirin resistance and heavy burden of thrombin activation in such patients. We have a large pool of patients with documented CAD (300-350/annum), and we will be able to enroll relatively large amount of quality patients fast.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omacor dose titration | – | Drug: Omacor, omega-3 fatty acids in CAD patientsStable documented coronary artery disease proven by angiography treated with statin and aspirin. In order to achieve homogeneity within this population, the following additional inclusion criteria will apply: * survived first-time AMI more than 12 months ago * stable medical treatment during the last 3 months (except removal of Plavix) * Ethnicity: Caucasians * Males, 50 - 60 yrs * non-diabetics * excluded are those who eat more than one meal of fish / week * excluded are those who take omega-3 supplements of any sorts |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Serial assessments of platelet characteristics from 10 patients in each of the 3 study groups at 2 time points for the total of 60 platelet samples. First, patients with stable coronary disease will be identified, telephone interviews will be conducted, and screening visits scheduled to those who qualify. We expect to triage 50 patients who then will be examined, and biochemistry markers tested. Patients will be allocated to one of three treatment arms based on randomization. Enrollment will continue until all 3 cells will be filled (n=10 each).
Key inclusion criteria (8 listed)
- Stable documented coronary artery disease proven by angiography treated with statin and aspirin. In order to achieve homogeneity within this population, the following additional inclusion criteria will apply:
- survived first-time AMI more than 12 mths ago
- stable medical treatment during the last 3 months (except removal of Plavix)
- Ethnicity: Caucasians
- Males, 50 - 60 yrs
Key exclusion criteria (11 listed)
- Thrombolytic therapy or GP IIb/IIIa inhibitor within 30 days of enrollment
- Platelet count < 100,000
- History of bleeding disorder
- Hct < 30, serum creatinine ≥3 mg/dL, liver impairment defined as ALT/AST > 3 times upper limit of normal.
- Glomerular filtration rate <50ml/min
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 |
|---|---|---|
| Omacor, omega-3 fatty acids in CAD patientsAlso: LovazaOmacor 1g versus 2g daily versus placebo | Drug | Omacor dose titration |
Primary outcome
Change in platelet aggregation after Lovaza® (1 or 2g/daily) in patients treated with aspirin + simvastatin versus those matched patients treated with placebo+aspirin +simvastatin in combination.
Time frame: Day 7 and Day 14
1 secondary outcome
Differences in expression of P-selectin and PAR-1 receptors after treatment with Lovaza® (1 or 2g/daily) in patients treated with aspirin + simvastatin versus those matched patients treated with placebo+aspirin +simvastatin in combination.
Time frame: Day 7 and Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
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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.
Alex Pokov, MD study chair
HeartDrug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by HeartDrug Research LLC 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilya Pokov, BS (410-371-6204, pokov3@comcast.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in platelet aggregation after Lovaza® (1 or 2g/daily) in patients treated with aspirin + simvastatin versus those matched patients treated with placebo+aspirin +simvastatin in combination. (time frame: Day 7 and Day 14). 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 12 Mar 2010.