Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01086163
Status:
UNKNOWN
Last Update Posted:
2010-03-12
First Post:
2010-03-11
Brief Title:
Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia
Sponsor:
HeartDrug Research LLC
Organization:
HeartDrug Research LLC
Study Overview
Official Title:
Effects of Prescription OMega-3 Fatty Acids Omacor Lovaza on Platelet Activity in Patients With Coronary Artery Disease With Hypertriglyceridemia OMPA-CAD
Status:
UNKNOWN
Status Verified Date:
2010-03
Last Known Status:
NOT_YET_RECRUITING
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:
OMPA-CAD
Brief Summary:
OmacorLovaza 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 OmacorLovaza 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
The investigators believe that OmacorLovaza 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 OmacorLovaza 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 OmacorLovaza 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 300-350annum and we will be able to enroll relatively large amount of quality patients fast
We believe that OmacorLovaza 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 300-350annum and we will be able to enroll relatively large amount of quality patients fast
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