Brief Summary

Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure. The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. The investigators propose that an antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory response and lead to a more favorable cardiac remodeling process.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jul 2010

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

July 1, 2010

Completed

29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

May 23, 2016

Completed

Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

2.2 years

First QC Date

July 30, 2010

Results QC Date

October 22, 2013

Last Update Submit

May 9, 2016

Conditions

Acute Myocardial Infarction Heart Failure

Keywords

Acute myocardial infarctionHeart FailureCardiac Remodeling

Outcome Measures

Primary Outcomes (1)

Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices
Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.
10-14 weeks minus baseline

Secondary Outcomes (15)

Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
10-14 weeks
Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)
10-14 weeks
Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks
10-14 weeks
Incidence of Heart Failure
10-14 weeks
Number of Adverse Events in Each Group
10-14 weeks
+10 more secondary outcomes

Study Arms (2)

Anakinra

EXPERIMENTAL

Anakinra 100 mg injectable subcutaneously daily

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

0.67 ml of sodium chloride (NaCl) 0.9% solution

Drug: Placebo

Interventions

AnakinraDRUG

Anakinra 100 mg s.c. daily for 14 days

Also known as: Kineret

Anakinra

PlaceboDRUG

0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days

Also known as: NaCl 0.9%

Placebo

Eligibility Criteria

Age18 Years - 110 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

age \> 18 years,
acute (\<12 h) onset of chest pain associated with ST segment elevation (\>2 mm) in 2 or more anatomically contiguous leads at ECG,
and successful primary percutaneous coronary intervention.

You may not qualify if:

inability to give informed consent,
late presentation (\>12 h),
unsuccessful revascularization procedure,
hemodynamic instability including hypotension,
prior Q-wave AMI,
end-stage congestive heart failure (American Heart Association \[AHA\]/American College of Cardiology \[ACC\] class C-D, New York Heart Association IV), severe left ventricular dysfunction (EF\<20%),
severe valvular heart disease,
pregnancy, dye allergy or contraindications to cardiac angiography and/or magnetic resonance imaging, coagulopathy (INR\>1.5 or platelet count\<50000/mm3),
recent (\<14 days) use of anti-inflammatory drugs (not including NSAIDs),
chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), and malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Virginia Commonwealth Universitylead
American Heart Associationcollaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

Abbate A, Kontos MC, Grizzard JD, Biondi-Zoccai GG, Van Tassell BW, Robati R, Roach LM, Arena RA, Roberts CS, Varma A, Gelwix CC, Salloum FN, Hastillo A, Dinarello CA, Vetrovec GW; VCU-ART Investigators. Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University Anakinra Remodeling Trial [VCU-ART] Pilot study). Am J Cardiol. 2010 May 15;105(10):1371-1377.e1. doi: 10.1016/j.amjcard.2009.12.059. Epub 2010 Apr 2.
PMID: 20451681BACKGROUND
Abbate A, Van Tassell BW, Biondi-Zoccai G, Kontos MC, Grizzard JD, Spillman DW, Oddi C, Roberts CS, Melchior RD, Mueller GH, Abouzaki NA, Rengel LR, Varma A, Gambill ML, Falcao RA, Voelkel NF, Dinarello CA, Vetrovec GW. Effects of interleukin-1 blockade with anakinra on adverse cardiac remodeling and heart failure after acute myocardial infarction [from the Virginia Commonwealth University-Anakinra Remodeling Trial (2) (VCU-ART2) pilot study]. Am J Cardiol. 2013 May 15;111(10):1394-400. doi: 10.1016/j.amjcard.2013.01.287. Epub 2013 Feb 27.
PMID: 23453459RESULT
Abbate A, Kontos MC, Abouzaki NA, Melchior RD, Thomas C, Van Tassell BW, Oddi C, Carbone S, Trankle CR, Roberts CS, Mueller GH, Gambill ML, Christopher S, Markley R, Vetrovec GW, Dinarello CA, Biondi-Zoccai G. Comparative safety of interleukin-1 blockade with anakinra in patients with ST-segment elevation acute myocardial infarction (from the VCU-ART and VCU-ART2 pilot studies). Am J Cardiol. 2015 Feb 1;115(3):288-92. doi: 10.1016/j.amjcard.2014.11.003. Epub 2014 Nov 13.
PMID: 25482680DERIVED
Sonnino C, Christopher S, Oddi C, Toldo S, Falcao RA, Melchior RD, Mueller GH, Abouzaki NA, Varma A, Gambill ML, Van Tassell BW, Dinarello CA, Abbate A. Leukocyte activity in patients with ST-segment elevation acute myocardial infarction treated with anakinra. Mol Med. 2014 Nov 18;20(1):486-9. doi: 10.2119/molmed.2014.00121.
PMID: 25121719DERIVED
Falcao RA, Christopher S, Oddi C, Reznikov L, Grizzard JD, Abouzaki NA, Varma A, Van Tassell BW, Dinarello CA, Abbate A. Interleukin-10 in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2014 Mar 1;172(1):e6-8. doi: 10.1016/j.ijcard.2013.12.126. Epub 2014 Jan 5. No abstract available.
PMID: 24467979DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Interleukin 1 Receptor Antagonist ProteinSodium Chloride

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title: Antonio Abbate
Organization: Virginia Commonwealth University

Study Officials

Antonio Abbate, M.D., Ph.D.
Virginia Commonwealth University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 4, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

May 23, 2016

Results First Posted

May 23, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing: Will not share

Locations

US(1)

Anakinra to Prevent Adverse Post-infarction Remodeling (2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Anakinra

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Anakinra

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations