Rationale and design of the Virginia Commonwealth University–Anakinra Remodeling Trial‐3 (VCU‐ART3): A randomized, placebo‐controlled, double‐blinded, multicenter study

There is clear association between the intensity of the acute inflammatory response during acute myocardial infarction (AMI) and adverse prognosis after AMI. Interleukin‐1 (IL‐1) is a pro‐inflammatory cytokine released during AMI and involved in adverse remodeling and heart failure (HF). We describe...

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Published in:	Clinical cardiology (Mahwah, N.J.) N.J.), 2018-08, Vol.41 (8), p.1004-1008
Main Authors:	Van Tassell, Benjamin W., Lipinski, Michael J., Appleton, Darryn, Roberts, Charlotte S., Kontos, Michael C., Abouzaki, Nayef, Melchior, Ryan, Mueller, George, Garnett, James, Canada, Justin, Carbone, Salvatore, Buckley, Leo F., Wohlford, George, Kadariya, Dinesh, Trankle, Cory R., Oddi Erdle, Claudia, Sculthorpe, Robin, Puckett, Laura, DeWilde, Christine, Shah, Keyur, Angiolillo, Dominick J., Vetrovec, George, Biondi‐Zoccai, Giuseppe, Arena, Ross, Abbate, Antonio
Format:	Article
Language:	eng
Subjects:	Antirheumatic Agents - administration & dosage Antirheumatic Agents - therapeutic use C-Reactive Protein - metabolism Cardiology Cytokines Dose-Response Relationship, Drug Double-Blind Method Echocardiography Electrocardiography Female Follow-Up Studies Heart attacks Heart Failure - diagnosis Heart Failure - epidemiology Heart Failure - etiology Heart Failure - prevention & control Humans Interleukin 1 Receptor Antagonist Protein - administration & dosage Interleukin-1 - blood Interleukin‐1 Male Middle Aged Morbidity - trends ST Elevation Myocardial Infarction - blood ST Elevation Myocardial Infarction - complications ST Elevation Myocardial Infarction - drug therapy STEMI study design Survival Rate - trends Treatment Outcome Trial Designs United States - epidemiology Ventricular Remodeling - drug effects
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Summary:	There is clear association between the intensity of the acute inflammatory response during acute myocardial infarction (AMI) and adverse prognosis after AMI. Interleukin‐1 (IL‐1) is a pro‐inflammatory cytokine released during AMI and involved in adverse remodeling and heart failure (HF). We describe a study to evaluate the safety and efficacy of IL‐1 blockade using an IL‐1 receptor antagonist (anakinra) during the acute phase of ST‐segment elevation myocardial infarction (STEMI). The Virginia Commonwealth University–Anakinra Remodeling Trial‐3 (VCU‐ART3; http://www.ClinicalTrials.gov NCT01950299) is a phase 2, multicenter, double‐blinded, randomized, placebo‐controlled clinical trial comparing anakinra 100 mg once or twice daily vs matching placebo (1:1:1) for 14 days in 99 patients with STEMI. Patients who present to the hospital with STEMI within 12 hours of symptom onset will be eligible for enrollment. Patients will be excluded for a history of HF (functional class III–IV), severe valvular disease, severe kidney disease (stage 4–5), active infection, recent use of immunosuppressive drugs, active malignancy, or chronic autoimmune/auto‐inflammatory diseases. We will measure the difference in the area under the curve for C‐reactive protein between admission and day 14, separately comparing each of the anakinra groups with the placebo group. The P value will be considered significant if
ISSN:	0160-9289 1932-8737