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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01950299
Acronym
VCU-ART3
Enrollment
99
Registered
2013-09-25
Start date
2014-07-01
Completion date
2018-12-23
Last updated
2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

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

Interventions

DRUGAnakinra 100 mg

Anakinra 100 mg starting immediately and then every 24 hours

DRUGPlacebo

Placebo 0.67 ml injections twice daily

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Left Ventricular End-systolic Volume12 monthsPlacebo corrected interval change in left ventricular end-systolic volume over 12 months
Left Ventricular Ejection Fraction12 monthsPlacebo-corrected interval changes in left ventricular ejection fraction over 12 months
Heart Failure12 monthsNew onset of heart failure symptoms (NYHA II-IV)

Countries

United States

Participant flow

Participants by arm

ArmCount
Anakinra (Standard Dose)
Anakinra 100 mg daily for 14 days
33
Anakinra (High Dose)
Anakinra 100 mg twice daily for 14 days
31
Placebo
Placebo for 14 days
35
Total99

Baseline characteristics

CharacteristicAnakinra (High Dose)PlaceboTotalAnakinra (Standard Dose)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants9 Participants19 Participants5 Participants
Age, Categorical
Between 18 and 65 years
26 Participants26 Participants80 Participants28 Participants
Age, Continuous55 years56 years55 years53 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
9 Participants6 Participants27 Participants12 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
22 Participants29 Participants72 Participants21 Participants
Region of Enrollment
United States
31 participants35 participants99 participants33 participants
Sex: Female, Male
Female
5 Participants5 Participants19 Participants9 Participants
Sex: Female, Male
Male
26 Participants30 Participants80 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 311 / 35
other
Total, other adverse events
6 / 338 / 311 / 35
serious
Total, serious adverse events
6 / 337 / 318 / 35

Outcome results

Primary

Acute Phase Response (CRP Levels)

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

Time frame: 14 days

ArmMeasureValue (MEDIAN)
Anakinra (Standard Dose)Acute Phase Response (CRP Levels)60.03 mg x day/L (milligram x day/liter)
Anakinra (High Dose)Acute Phase Response (CRP Levels)86.35 mg x day/L (milligram x day/liter)
PlaceboAcute Phase Response (CRP Levels)213.75 mg x day/L (milligram x day/liter)
Secondary

Heart Failure

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

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Anakinra (Standard Dose)Heart Failure3 Participants
Anakinra (High Dose)Heart Failure3 Participants
PlaceboHeart Failure9 Participants
Secondary

Left Ventricular Ejection Fraction

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

Time frame: 12 months

ArmMeasureValue (MEDIAN)
Anakinra (Standard Dose)Left Ventricular Ejection Fraction4 % (Left ventricular ejection fraction)
Anakinra (High Dose)Left Ventricular Ejection Fraction5 % (Left ventricular ejection fraction)
PlaceboLeft Ventricular Ejection Fraction3 % (Left ventricular ejection fraction)
Secondary

Left Ventricular End-systolic Volume

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

Time frame: 12 months

ArmMeasureValue (MEDIAN)
Anakinra (Standard Dose)Left Ventricular End-systolic Volume0 mL (milliliters)
Anakinra (High Dose)Left Ventricular End-systolic Volume4 mL (milliliters)
PlaceboLeft Ventricular End-systolic Volume-4 mL (milliliters)

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026