The Effects of Lovaza® in Acute Myocardial Infarction

NCT01155336 | Terminated Phase 1 Results DMC

• 1 other identifier: LVZ114193
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Acute Coronary Syndrome; Fish Oils; Platelet Function Tests; Cardiac Electrophysiology

Outcome Measures

Primary Outcomes (1)

• 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.

  12 hours

Secondary Outcomes (1)

• Cardiac Electrophysiology

  1 week

Study Arms (2)

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.

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.

Drug: The placebo contained 1 gram of corn oil in each capsule.

Interventions

Lovaza® DRUG

Lovaza® is prescription grade EPA+DHA fish oil supplement.

Also known as: Fish oil

Lovaza®

The placebo contained 1 gram of corn oil in each capsule. DRUG

Placebo Pill

Also known as: Corn oil

Corn Oil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• GlaxoSmithKline: collaborator
• Albany College of Pharmacy and Health Sciences: collaborator

Study Sites (1)

University or Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome

Interventions

Omacor; Fish Oils; Corn Oil

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

no adverse events

Results Point of Contact

• Title: Dr. Robert Block
• Organization: University of Rochester

robert_block@urmc.rochester.edu

585 275-3356

Study Officials

• Robert Block, MD, MPH

  University or Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 6, 2017
• Results First Posted: March 11, 2013

Record last verified: 2017-10

Locations

US (1)