The Effects of Lovaza® in Acute Myocardial Infarction

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborators: Albany College of Pharmacy and Health Sciences; GlaxoSmithKline

Criteria

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)