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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Acute Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT01950299

Run by

Virginia Commonwealth University

People needed

99

Starts

2014-07-01

Expected to finish

2018-12-23

Last updated by the study team

2019-12-18

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and NONE of the Exclusion criteria.
• 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
• Planned or completed coronary angiogram for potential intervention
• Age>21

You may not qualify if…

• 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)

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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