Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)

• Status: Completed
• Trial end date: 2018-12-23
• Target enrollment: 0
• Participant gender: All

Summary

VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI) measuring the effects on the acute rise and fall of the plasma C reactive protein levels during the first 14 days.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

INCLUSION CRITERIA:

In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and NONE of the Exclusion criteria.

1. Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new

2. Planned or completed coronary angiogram for potential intervention

3. Age>21

EXCLUSION CRITERIA:

• Inability to give informed consent

• Pregnancy

• Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)

• Preexisting severe left ventricular dysfunction (EF<20%)

• Preexisting severe valvular heart disease

• Active infections (acute or chronic) - excluding Hepatitis C Virus (HCV)+ with undetectable RNA

• Recent (<14 days) or active use of anti-inflammatory drugs (not including non-steroidal anti-inflammatory drugs [NSAIDs] or corticosteroids used for IV dye allergy only)

• Chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)

• Active malignancy - excluding carcinoma in situ [any organ] and non-melanoma skin cancer

• Anticipated need for cardiac surgery

• Neutropenia (absolute neutrophil count<1,800/mm3)