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

Last updated: December 3, 2019
Sponsor: Virginia Commonwealth University
Overall Status: Completed

Phase

2/3

Condition

Myocardial Ischemia

Heart Disease

Angina

Treatment

N/A

Clinical Study ID

NCT01950299
HM20000024
1R34HL121402-01
  • Ages 21-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA: In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria andNONE of the Exclusion criteria.

  1. Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours andECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguousleads that is new or presumably new

  2. Planned or completed coronary angiogram for potential intervention

  3. Age>21

Exclusion

EXCLUSION CRITERIA:

  • Inability to give informed consent

  • Pregnancy

  • Preexisting congestive heart failure (American Heart Association/American College ofCardiology 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)+ withundetectable RNA

  • Recent (<14 days) or active use of anti-inflammatory drugs (not includingnon-steroidal anti-inflammatory drugs [NSAIDs] or corticosteroids used for IV dyeallergy 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 skincancer

  • Anticipated need for cardiac surgery

  • Neutropenia (absolute neutrophil count<1,800/mm3)

Study Design

Total Participants: 99
Study Start date:
July 01, 2014
Estimated Completion Date:
December 23, 2018

Study 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

Connect with a study center

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Washington Hospital Center

    Washington DC, District of Columbia 20010
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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