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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anakinra 100 mg
Anakinra 100 mg
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Washington Hospital Center
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Anakinra (standard dose)

Anakinra (high dose)

Placebo

Arm Description

Anakinra 100 mg daily for 14 days

Anakinra 100 mg twice daily for 14 days

Placebo for 14 days

Outcomes

Primary Outcome Measures

Acute Phase Response (CRP Levels)
Comparison of area-under-the-curve for CRP up to day 14

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2013
Last Updated
December 3, 2019
Sponsor
Virginia Commonwealth University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01950299
Brief Title
Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)
Acronym
VCU-ART3
Official Title
Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction - the Virginia Commonwealth University Anakinra Remodeling Trial 3
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
December 23, 2018 (Actual)
Study Completion Date
December 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anakinra (standard dose)
Arm Type
Experimental
Arm Description
Anakinra 100 mg daily for 14 days
Arm Title
Anakinra (high dose)
Arm Type
Experimental
Arm Description
Anakinra 100 mg twice daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 14 days
Intervention Type
Drug
Intervention Name(s)
Anakinra 100 mg
Other Intervention Name(s)
Kineret
Intervention Description
Anakinra 100 mg starting immediately and then every 24 hours
Intervention Type
Drug
Intervention Name(s)
Anakinra 100 mg
Other Intervention Name(s)
Kineret
Intervention Description
Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo injections twice daily
Intervention Description
Placebo 0.67 ml injections twice daily
Primary Outcome Measure Information:
Title
Acute Phase Response (CRP Levels)
Description
Comparison of area-under-the-curve for CRP up to day 14
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Left Ventricular End-systolic Volume
Description
Placebo corrected interval change in left ventricular end-systolic volume over 12 months
Time Frame
12 months
Title
Left Ventricular Ejection Fraction
Description
Placebo-corrected interval changes in left ventricular ejection fraction over 12 months
Time Frame
12 months
Title
Heart Failure
Description
New onset of heart failure symptoms (NYHA II-IV)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Abbate, MD, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32648087
Citation
Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9.
Results Reference
derived
PubMed Identifier
32122219
Citation
Abbate A, Trankle CR, Buckley LF, Lipinski MJ, Appleton D, Kadariya D, Canada JM, Carbone S, Roberts CS, Abouzaki N, Melchior R, Christopher S, Turlington J, Mueller G, Garnett J, Thomas C, Markley R, Wohlford GF, Puckett L, Medina de Chazal H, Chiabrando JG, Bressi E, Del Buono MG, Schatz A, Vo C, Dixon DL, Biondi-Zoccai GG, Kontos MC, Van Tassell BW. Interleukin-1 Blockade Inhibits the Acute Inflammatory Response in Patients With ST-Segment-Elevation Myocardial Infarction. J Am Heart Assoc. 2020 Mar 3;9(5):e014941. doi: 10.1161/JAHA.119.014941. Epub 2020 Mar 3.
Results Reference
derived
PubMed Identifier
30033595
Citation
Van Tassell BW, Lipinski MJ, Appleton D, Roberts CS, Kontos MC, Abouzaki N, Melchior R, Mueller G, Garnett J, Canada J, Carbone S, Buckley LF, Wohlford G, Kadariya D, Trankle CR, Oddi Erdle C, Sculthorpe R, Puckett L, DeWilde C, Shah K, Angiolillo DJ, Vetrovec G, Biondi-Zoccai G, Arena R, Abbate A. Rationale and design of the Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3): A randomized, placebo-controlled, double-blinded, multicenter study. Clin Cardiol. 2018 Aug;41(8):1004-1008. doi: 10.1002/clc.22988. Epub 2018 Aug 17.
Results Reference
derived

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

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