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Completed

NCT Number: NCT01950299

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

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.

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Washington Hospital Center, Washington D.C., District of Columbia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anakinra 100 mg

Drug

Anakinra 100 mg starting immediately and then every 24 hours

Other names: Kineret

Placebo

Drug

Placebo 0.67 ml injections twice daily

Other names: Placebo injections twice daily

Primary outcomes

  1. Acute Phase Response (CRP Levels)

    Time frame: 14 days

    Comparison of area-under-the-curve for CRP up to day 14

Secondary outcomes

  1. Left Ventricular End-systolic Volume

    Time frame: 12 months

    Placebo corrected interval change in left ventricular end-systolic volume over 12 months

  2. Left Ventricular Ejection Fraction

    Time frame: 12 months

    Placebo-corrected interval changes in left ventricular ejection fraction over 12 months

  3. Heart Failure

    Time frame: 12 months

    New onset of heart failure symptoms (NYHA II-IV)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: VCU-ART3

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2013
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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