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

NCT01950299 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HM200000241R34HL121402-01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Acute Phase Response (CRP Levels)

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

  14 days

Secondary Outcomes (3)

• Left Ventricular End-systolic Volume

  12 months

• Left Ventricular Ejection Fraction

  12 months

• Heart Failure

  12 months

Study Arms (3)

Anakinra (standard dose)

EXPERIMENTAL

Anakinra 100 mg daily for 14 days

Drug: Anakinra 100 mg; Drug: Placebo

Anakinra (high dose)

EXPERIMENTAL

Anakinra 100 mg twice daily for 14 days

Drug: Anakinra 100 mg

Placebo

PLACEBO COMPARATOR

Placebo for 14 days

Drug: Placebo

Interventions

Anakinra 100 mg DRUG

Anakinra 100 mg starting immediately and then every 24 hours

Also known as: Kineret

Anakinra (high dose); Anakinra (standard dose)

Placebo DRUG

Placebo 0.67 ml injections twice daily

Also known as: Placebo injections twice daily

Anakinra (standard dose); Placebo

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• 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.

  PMID: 32648087 DERIVED

• 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.

  PMID: 32122219 DERIVED

• 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.

  PMID: 30033595 DERIVED

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Antonio Abbate, MD, PhD
• Organization: Virginia Commonwealth University

antonio.abbate@vcuhealth.org

804-828-0513

Study Officials

• Antonio Abbate, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 4, 2013
• First Posted: September 25, 2013
• Study Start: July 1, 2014
• Primary Completion: December 23, 2018
• Study Completion: December 23, 2018
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-12

Locations

US (2)