A Phase 1/2 interventional study of Lovaza® and The placebo contained 1 gram of corn oil in each capsule. in Myocardial Infarction, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by University of Rochester · Phase 1/2, Interventional, and Treatment
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 4 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Acute myocardial infarction documented by at least 2 of the following:
Exclusion Criteria:
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.
Drug: Lovaza®
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.
Drug: The placebo contained 1 gram of corn oil in each capsule.
Lovaza® is prescription grade EPA+DHA fish oil supplement.
Also known as: Fish oil
Placebo Pill
Also known as: Corn oil
Platelet Function
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.
Time frame: 12 hours
Cardiac Electrophysiology
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.
Time frame: 1 week
| Milestone | Corn Oil | Lovaza® |
|---|---|---|
| Started | 0 | 4 |
| Completed | 0 | 4 |
| Not completed | 0 | 0 |
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.
| seconds | Corn Oil | Lovaza® |
|---|---|---|
| Platelet Function | — | 130.25 (101 to 190) |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Corn Oil | — | — | — |
| Lovaza® | — | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Corn Oil | Lovaza® | Total |
|---|---|---|---|
| <=18 years | — | 0 | 0 |
| Between 18 and 65 years | — | 3 | 3 |
| >=65 years | — | 1 | 1 |
| Age, Continuous(years) | Corn Oil | Lovaza® | Total |
|---|---|---|---|
| Mean | — | 60.25 ± 10 | 60.25 ± 10 |
| Sex: Female, Male(Participants) | Corn Oil | Lovaza® | Total |
|---|---|---|---|
| Female | — | 1 | 1 |
| Male | — | 3 | 3 |
| Region of Enrollment(participants) | Corn Oil | Lovaza® | Total |
|---|---|---|---|
| United States | — | 4 | 4 |
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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