Myocardial InfarctionPhase 1/2OmegaMINCT01155336
The Effects of Lovaza® in Acute Myocardial Infarction
A Phase 1/2 study testing Lovaza® in people with Myocardial Infarction, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Lovaza®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Lovaza®, The placebo contained 1 gram of corn oil in each capsule.
- Keywords
- Acute Coronary Syndrome, Fish Oils, Platelet Function Tests, Cardiac Electrophysiology
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza®Drug
Also called Fish oil
Lovaza® is prescription grade EPA+DHA fish oil supplement.
The placebo contained 1 gram of corn oil in each capsule.Drug
Also called Corn oil
Placebo Pill
| Study group | Role | What they receive |
|---|---|---|
| Lovaza® | Experimental | 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. Receives: Drug: Lovaza® |
| Corn Oil | Placebo comparator | 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. Receives: Drug: The placebo contained 1 gram of corn oil in each capsule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours
Secondary outcomes (1)
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Only 5 individuals were able to be recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Albany College of Pharmacy and Health Sciences
- Responsible party
- Principal investigator, Robert Block, University of Rochester
- Investigators
- Robert Block, MD, MPH, Principal investigator, University or Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155336
- Sponsor's protocol ID
- LVZ114193
- Acronym
- OmegaMI
- Status last verified
- Oct 2017
- First submitted
- 25 Jun 2010
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lovaza® on Platelet Function and Cardiac Electrophysiology in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01155336
- Acronym / sponsor ID
- OmegaMI / LVZ114193
- Conditions
- Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, Fish Oils, Platelet Function Tests, Cardiac Electrophysiology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 5 individuals were able to be recruited.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Albany College of Pharmacy and Health Sciences
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 11 Mar 2013
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 safety and effectiveness of adding Lovaza® to the therapeutic program utilized internationally for the treatment of individuals with acute coronary syndromes.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovaza® | Experimental | Drug: 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. |
| Corn Oil | Placebo comparator | Drug: The placebo contained 1 gram of corn oil in each capsule.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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acute myocardial infarction documented by at least 2 of the following:
- 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.
Key exclusion criteria (21 listed)
- No informed consent
- Daily aspirin use prior to index hospitalization
- Known prior myocardial infarction
- Known pregnancy
- Known allergy to fish, fish oil, or aspirin
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 |
|---|---|---|
| Lovaza®Also: Fish oilLovaza® is prescription grade EPA+DHA fish oil supplement. | Drug | Lovaza® |
| The placebo contained 1 gram of corn oil in each capsule.Also: Corn oilPlacebo Pill | Drug | Corn Oil |
Primary outcome
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.
1 secondary outcome
Cardiac Electrophysiology
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Block, MD, MPH principal investigator
University or Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lovaza® in people with Myocardial Infarction, run by University of Rochester 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 21 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: stopped early, as of the sponsor's last update on 6 Nov 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Platelet Function (time frame: 12 hours). 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 6 Nov 2017.