- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01155336
The Effects of Lovaza® in Acute Myocardial Infarction (OmegaMI)
October 5, 2017 updated by: Robert Block, University of Rochester
The Effects of Lovaza® on Platelet Function and Cardiac Electrophysiology in Acute Myocardial Infarction
This study will explore the safety and effectiveness of adding Lovaza® to the therapeutic program utilized internationally for the treatment of individuals with acute coronary syndromes.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Atherosclerotic cardiovascular disease is the cause for over 19 million deaths in the US annually with coronary artery disease accounting for most of this mortality burden.1 Despite major advances in the treatment of coronary heart disease patients, a large number of victims of the disease who are apparently healthy die suddenly without prior symptoms.
For those who arrive alive at an emergency department, a benefit is accrued from an orchestrated program of live-saving therapeutics designed to preserve ischemic or infarcted myocardium and prevent ventricular arrhythmias.
However, despite improvements in door-to-balloon (angioplasty) times in the past decade, reductions in in-hospital mortality have not materialized.2
Average 30-day mortality from ST elevation MI has been shown to be approximately 7% despite the modern aggressive approach of utilizing acute pharmacologic and percutaneous interventions as well as a comprehensive approach to risk factor modification.3 Antiplatelet agents including aspirin, clopidogrel, heparin, and IIb/IIIa inhibitors represent stalwart components of the acute coronary syndrome therapeutic treatment program.
At the same time, the safety of combination antiplatelet agents used acutely and chronically in individuals with an acute coronary syndrome is concerning as bleeding complications can result in serious, life-threatening consequences.4
Studies have shown that patients treated with the combination of aspirin and clopidogrel have a small but significant increased risk of major and minor bleeding compared to each agent alone.4-6
In contrast, the use of fish oil in conjunction with aspirin and clopidogrel in patients with cardiovascular disease followed for an average of 33 months has been shown to have no significant effect on risk of major and minor bleeding compared to those on aspirin and clopidogrel alone, with a trend toward a reduced risk of minor bleeding in those taking fish oil.4
In Preliminary Data it is shown that a robust synergistic effect between Lovaza® and aspirin on the downregulation of platelet function may occur.
These data suggest that the most potent omega-3 fatty acids found in fish oil (eicosapentaenoic acid {EPA} and docosahexaenoic acid {DHA}) act acutely to modulate a major contributor to the pathophysiology of acute coronary syndromes.
This study will randomize 60 patients with ST elevation myocardial infarction to treatment with Lovaza® or placebo and measure the differences in platelet function and electrophysiologic parameters between treatment arms during their acute hospitalization and 1 week after discharge.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Rochester, New York, United States, 14642
- University or Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Acute myocardial infarction documented by at least 2 of the following:
- Typical symptoms
- Abnormal levels of cardiac biomarkers (troponin I or T or CK-MB mass) with at least one determination > 99th percentile or ULN for the laboratory
- ECG findings diagnostic of myocardial infarction based on the American College of Cardiology criteria.
- Status-post urgent or emergent PCI
- Have a Thrombolysis In Myocardial Infarction (TIMI) flow grade = 3 (complete perfusion) post PCI.
- Have the capacity for informed consent (e.g. without significant dementia or sedation from medication)
- Ingested 325 mg of chewed aspirin as part of the acute coronary syndrome treatment protocol.
Exclusion Criteria:
- No informed consent
- Daily aspirin use prior to index hospitalization
- Known prior myocardial infarction
- Known pregnancy
- Known allergy to fish, fish oil, or aspirin
- Known active internal or non-superficial bleeding, known bleeding disorder, coagulation defect, or thrombocytopenia
- Thrombolysis in the past 12 hours
- Treatment with a IIbIIIa inhibitor during index hospitalization
- Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg
- Severe uncontrolled hypertension (≥180/110) or hypertensive retinopathy
- A history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal (not hemorrhoidal) or genitourinary bleeding in the past 6 weeks
- A history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
- A known arteriovenous malformation or aneurysm
- Severe liver insufficiency (ALT ≥ 3 times normal)
- Renal insufficiency requiring dialysis
- A known diagnosis of vasculitis
- Participation in another clinical study
- History of malignancy, except subjects who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
- Oral contraceptive use
- Daily use of NSAIDs
- History of drug or alcohol abuse, or current weekly alcohol consumption >14 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 shot of alcohol)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lovaza®
Lovaza® is a prescription grade EPA+DHA fish oil supplement.
Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
|
Lovaza® is prescription grade EPA+DHA fish oil supplement.
Other Names:
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Placebo Comparator: Corn Oil
The placebo contained 1 gram of corn oil in each capsule.
Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
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Placebo Pill
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet Function
Time Frame: 12 hours
|
Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis.
The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine.
It is meant to imitate clotting in human arteries.
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12 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Electrophysiology
Time Frame: 1 week
|
A 20-minute supine 12-lead Holter ECG will allow the quantification of a series of standard ECG parameters as well as provide insight into frequency-domain HRV parameters, QRS duration and morphology, using signal-averaged ECG (SAECG), repolarization morphology, and variability utilizing specialized programs.
|
1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Block, MD, MPH, University or Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
June 25, 2010
First Submitted That Met QC Criteria
June 30, 2010
First Posted (Estimate)
July 1, 2010
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
October 5, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LVZ114193
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
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Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
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University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
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Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
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Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
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Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
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Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
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Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
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University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
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Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
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Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on Lovaza®
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AstraZenecaCompletedSevere HypertriglyceridemiaUnited States, Canada
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University of MichiganGlaxoSmithKlineTerminated
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University of VirginiaReliant PharmaceuticalsWithdrawn
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University of TennesseeUnknownParenteral Nutrition Associated Liver DiseaseUnited States
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St. Luke's-Roosevelt Hospital CenterGlaxoSmithKlineNo longer available
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University of UtahGlaxoSmithKlineWithdrawnEffects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in HypertriglyceridemiaHypertriglyceridemiaUnited States
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University of Illinois at ChicagoTerminatedNonalcoholic Steatohepatitis (NASH) | Hepatic SteatosisUnited States
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Milton S. Hershey Medical CenterWithdrawn
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Brigham and Women's HospitalGlaxoSmithKlineUnknown
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Vanderbilt UniversityNational Cancer Institute (NCI)CompletedColorectal Adenomatous PolypsUnited States