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

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ClinicalTrials.gov Identifier: NCT01950299
Recruitment Status : Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Anakinra 100 mg Drug: Placebo Phase 2 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction - the Virginia Commonwealth University Anakinra Remodeling Trial 3
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : January 1, 2018
Estimated Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Anakinra
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Anakinra (standard dose)
Anakinra 100 mg daily for 14 days
Drug: Anakinra 100 mg
Anakinra 100 mg starting immediately and then every 24 hours
Other Name: Kineret
Drug: Placebo
Placebo 0.67 ml injections twice daily
Other Name: Placebo injections twice daily
Experimental: Anakinra (high dose)
Anakinra 100 mg twice daily for 14 days
Drug: Anakinra 100 mg
Anakinra 100 mg starting immediately and then every 24 hours
Other Name: Kineret
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)
Other Name: Kineret
Placebo Comparator: Placebo
Placebo for 14 days
Drug: Placebo
Placebo 0.67 ml injections twice daily
Other Name: Placebo injections twice daily



Primary Outcome Measures :
  1. Acute phase response (CRP levels) [ Time Frame: 14 days ]
    Placebo corrected difference in the area-under-the-curve for CRP up to day 14


Secondary Outcome Measures :
  1. Left ventricular end-systolic volume indices change [ Time Frame: 12 months ]
    Placebo corrected interval change in left ventricular end-systolic volume indices 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)



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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (or prior malignancy within the past 10 years) - excluding carcinoma in situ [any organ] and non-melanoma skin cancer
  • Anticipated need for cardiac surgery
  • Neutropenia (absolute neutrophil count<1,800/mm3)
  • Need for vaccination or desensitization that cannot be postponed for 14 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950299


Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01950299     History of Changes
Other Study ID Numbers: HM20000024
1R34HL121402-01 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents