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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Drug: Anakinra 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01950299

1R34HL121402-01 (U.S. NIH Grant/Contract)

HM20000024

Details and patient eligibility

About

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.

Full description

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

Enrollment: 99 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

Anakinra (standard dose)

Experimental group

Description:

Anakinra 100 mg daily for 14 days

Treatment:

Drug: Placebo

Drug: Anakinra 100 mg

Drug: Anakinra 100 mg

Anakinra (high dose)

Experimental group

Description:

Anakinra 100 mg twice daily for 14 days

Treatment:

Drug: Anakinra 100 mg

Drug: Anakinra 100 mg

Placebo

Placebo Comparator group

Description:

Placebo for 14 days

Treatment:

Drug: Placebo