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Acute Myocardial InfarctionPhase 2/3VCU-ART3NCT01950299

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

A Phase 2/3 study testing Anakinra 100 mg in people with Acute Myocardial Infarction, run by Virginia Commonwealth University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Anakinra 100 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
2 sitesUnited States
Study dates
1 Jul 2014to 23 Dec 2018
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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

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.

Read the 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

Being tested
Anakinra 100 mg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anakinra 100 mgDrug

    Also called Kineret

    Anakinra 100 mg starting immediately and then every 24 hours

  • Anakinra 100 mgDrug

    Also called Kineret

    Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours)

  • PlaceboDrug

    Also called Placebo injections twice daily

    Placebo 0.67 ml injections twice daily

Study groups in NCT01950299
Study groupRoleWhat they receive
Anakinra (standard dose)ExperimentalAnakinra 100 mg daily for 14 days
Receives: Drug: Anakinra 100 mg; Drug: Placebo
Anakinra (high dose)ExperimentalAnakinra 100 mg twice daily for 14 days
Receives: Drug: Anakinra 100 mg
PlaceboPlacebo comparatorPlacebo for 14 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Phase Response (CRP Levels)

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

    Measured: 14 days

Secondary outcomes (3)

  1. Left Ventricular End-systolic Volume

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

    Measured: 12 months

  2. Left Ventricular Ejection Fraction

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

    Measured: 12 months

  3. Heart Failure

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2013 (estimated)
  2. Study start1 Jul 2014
  3. Primary completion23 Dec 2018
  4. Study completion23 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01950299
Sponsor's protocol ID
HM20000024
Other IDs
1R34HL121402-01
Acronym
VCU-ART3
Status last verified
Dec 2019
First submitted
4 Sep 2013
Last updated
18 Dec 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Denicolai M, Morello M, Golino M, Corna G, Del Buono MG, Agatiello CR, Van Tassell BW, Abbate A. Interleukin-1 Blockade in Patients With ST-Segment Elevation Myocardial Infarction Across the Spectrum of Coronary Artery Disease Complexity. J Cardiovasc Pharmacol. 2025 Mar 1;85(3):200-210. doi: 10.1097/FJC.0000000000001652.

    PubMed 39531530

  • Moroni F, Corna G, Del Buono MG, Golino M, Talasaz AH, Decotto S, Markley R, Trankle C, Biondi-Zoccai G, Carbone S, Agatiello CR, Van Tassell B, Abbate A. Impact of C-reactive protein levels and role of anakinra in patients with ST-elevation myocardial infarction. Int J Cardiol. 2024 Mar 1;398:131610. doi: 10.1016/j.ijcard.2023.131610. Epub 2023 Nov 26.

    PubMed 38016623

  • 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.

    PubMed 32648087

  • 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.

    PubMed 32122219

  • 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.

    PubMed 30033595

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Anakinra 100 mg in people with Acute Myocardial Infarction, run by Virginia Commonwealth University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Phase Response (CRP Levels) (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01950299, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.

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