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

Overview

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 Title of Study: “Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction – the Virginia Commonwealth University Anakinra Remodeling Trial 3”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 23, 2018

Detailed 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

Interventions

  • Drug: Anakinra 100 mg
    • Anakinra 100 mg starting immediately and then every 24 hours
  • Drug: Anakinra 100 mg
    • Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours)
  • Drug: Placebo
    • Placebo 0.67 ml injections twice daily

Arms, Groups and Cohorts

  • Experimental: Anakinra (standard dose)
    • Anakinra 100 mg daily for 14 days
  • Experimental: Anakinra (high dose)
    • Anakinra 100 mg twice daily for 14 days
  • Placebo Comparator: Placebo
    • Placebo for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • Acute Phase Response (CRP Levels)
    • Time Frame: 14 days
    • Comparison of area-under-the-curve for CRP up to day 14

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Antonio Abbate, MD, PhD, Principal Investigator, Virginia Commonwealth University

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