The Effects of Lovaza® in Acute Myocardial Infarction

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT01155336

Run by

University of Rochester

People needed

4

Starts

2010-06-01

Expected to finish

2011-05-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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)

Where it is running

• University or Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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