OmegaMI: The Effects of Lovaza® in Acute Myocardial Infarction

• Sponsor: University of Rochester (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01155336
• Collaborator: GlaxoSmithKline (Industry), Albany College of Pharmacy and Health Sciences (Other)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Lovaza®; Drug: The placebo contained 1 gram of corn oil in each capsule.	Phase 1/Phase 2

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 and docosahexaenoic acid ) 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

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Lovaza® on Platelet Function and Cardiac Electrophysiology in Acute Myocardial Infarction
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

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.	Drug: Lovaza®; Lovaza® is prescription grade EPA+DHA fish oil supplement.; Other Names: Fish oil
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.	Drug: The placebo contained 1 gram of corn oil in each capsule.; Placebo Pill; Other Names: Corn oil

Outcome Measures

Primary Outcome Measures

1. Platelet Function [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.

Secondary Outcome Measures

1. Cardiac Electrophysiology [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute myocardial infarction documented by at least 2 of the following:

1. Typical symptoms

2. 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

3. 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University or Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• GlaxoSmithKline
• Albany College of Pharmacy and Health Sciences

Investigators

• Principal Investigator: Robert Block, MD, MPH, University or Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Block, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01155336
• Other Study ID Numbers: LVZ114193
• First Posted: Jul 1, 2010
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Robert Block, Assistant Professor, University of Rochester: Acute Coronary Syndrome; Fish Oils; Platelet Function Tests; Cardiac Electrophysiology
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	Corn Oil	Lovaza®
Arm/Group Description	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. The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill	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® : Lovaza® is prescription grade EPA+DHA fish oil supplement.
Period Title: Overall Study
STARTED	0	4
COMPLETED	0	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Corn Oil	Lovaza®	Total
Arm/Group Description	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. The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill	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® : Lovaza® is prescription grade EPA+DHA fish oil supplement.	Total of all reporting groups
Overall Participants	0	4	4
Age (Count of Participants)
<=18 years	0 NaN	0 0%
Between 18 and 65 years	3 Infinity	3 75%
>=65 years	1 Infinity	1 25%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.25 (10)	60.25 (10)
Sex: Female, Male (Count of Participants)
Female	1 Infinity	1 25%
Male	3 Infinity	3 75%
Region of Enrollment (participants) [Number]
United States	4 Infinity	4 100%

Outcome Measures

1. Primary Outcome

Title	Platelet Function
Description	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

Outcome Measure Data

Analysis Population Description

We did not complete the study and no subjects were randomized to corn oil

Arm/Group Title	Corn Oil	Lovaza®
Arm/Group Description	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. The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill	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® : Lovaza® is prescription grade EPA+DHA fish oil supplement.
Measure Participants	0	4
Mean (Full Range) [seconds]	130.25

2. Secondary Outcome

Title	Cardiac Electrophysiology
Description	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

Outcome Measure Data

Analysis Population Description

Data was not collected for this outcome measure.

Arm/Group Title	Corn Oil	Lovaza®
Arm/Group Description	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. The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill	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® : Lovaza® is prescription grade EPA+DHA fish oil supplement.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Corn Oil		Lovaza®
Arm/Group Description	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. The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill		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® : Lovaza® is prescription grade EPA+DHA fish oil supplement.
All Cause Mortality
	Corn Oil		Lovaza®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Corn Oil		Lovaza®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Corn Oil		Lovaza®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/4 (0%)

Limitations/Caveats

no adverse events

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.