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

NCT ID: NCT01950299

Last Updated: 2019-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2018-12-23

Brief Summary

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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

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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

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anakinra (standard dose)

Anakinra 100 mg daily for 14 days

Group Type EXPERIMENTAL

Anakinra 100 mg

Intervention Type DRUG

Anakinra 100 mg starting immediately and then every 24 hours

Placebo

Intervention Type DRUG

Placebo 0.67 ml injections twice daily

Anakinra (high dose)

Anakinra 100 mg twice daily for 14 days

Group Type EXPERIMENTAL

Anakinra 100 mg

Intervention Type DRUG

Anakinra 100 mg starting immediately and then every 24 hours

Anakinra 100 mg

Intervention Type DRUG

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

Placebo

Placebo for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 0.67 ml injections twice daily

Interventions

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Anakinra 100 mg

Anakinra 100 mg starting immediately and then every 24 hours

Intervention Type DRUG

Anakinra 100 mg

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

Placebo

Placebo 0.67 ml injections twice daily

Intervention Type DRUG

Other Intervention Names

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Kineret Kineret Placebo injections twice daily

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Abbate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Washington Hospital Center

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

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32648087 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32122219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30033595 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R34HL121402-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20000024

Identifier Type: -

Identifier Source: org_study_id