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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction - the Virginia Commonwealth University Anakinra Remodeling Trial 3

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Anakinra 100 mg
* Drug: Anakinra 100 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: 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 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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anakinra (standard dose)<br>Anakinra 100 mg daily for 14 days | Drug: Anakinra 100 mg<br>* Anakinra 100 mg starting immediately and then every 24 hours<br>* Other names: Kineret;Drug: Placebo<br>* Placebo 0.67 ml injections twice daily<br>* Other names: Placebo injections twice daily;|
| Experimental: Anakinra (high dose)<br>Anakinra 100 mg twice daily for 14 days | Drug: Anakinra 100 mg<br>* Anakinra 100 mg starting immediately and then every 24 hours<br>* Other names: Kineret;Drug: Anakinra 100 mg<br>* Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours)<br>* Other names: Kineret;|
| Placebo Comparator: Placebo<br>Placebo for 14 days | Drug: Placebo<br>* Placebo 0.67 ml injections twice daily<br>* Other names: Placebo injections twice daily;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Phase Response (CRP Levels) | Comparison of area-under-the-curve for CRP up to day 14 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular End-systolic Volume | Placebo corrected interval change in left ventricular end-systolic volume over 12 months | 12 months | 
| Left Ventricular Ejection Fraction | Placebo-corrected interval changes in left ventricular ejection fraction over 12 months | 12 months | 
| Heart Failure | New onset of heart failure symptoms (NYHA II-IV) | 12 months |