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

Clinical Cardiology

Volumn 41, Issue 8, 2018, Pages 1004-1008

  Van Tassell, Benjamin W ^a   Lipinski, Michael J ^b   Appleton, Darryn ^c   Roberts, Charlotte S ^a   Kontos, Michael C ^a   Abouzaki, Nayef ^a   Melchior, Ryan ^a,c   Mueller, George ^a,c   Garnett, James ^c   Canada, Justin ^a   Carbone, Salvatore ^a   Buckley, Leo F ^a   Wohlford, George ^a   Kadariya, Dinesh ^a   Trankle, Cory R ^a   Oddi Erdle, Claudia ^a   Sculthorpe, Robin ^a   Puckett, Laura ^a,c   DeWilde, Christine ^a   Shah, Keyur ^a   Angiolillo, Dominick J ^f   Vetrovec, George ^a   Biondi Zoccai, Giuseppe ^d   Arena, Ross ^e   Abbate, Antonio ^a   more..

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b WASHINGTON HOSPITAL CENTER   (United States)

^c Virginia Cardiovascular Specialists   (United States)

^d SAPIENZA UNIVERSITY OF ROME   (Italy)

^e UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^f UNIVERSITY OF FLORIDA   (United States)

Author keywords

Interleukin 1; STEMI; study design

Indexed keywords

ANAKINRA; C REACTIVE PROTEIN; PLACEBO; ANTIRHEUMATIC AGENT; INTERLEUKIN 1; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT;

ADULT; ARTICLE; CARDIOVASCULAR MORTALITY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ECHOCARDIOGRAPHY; FEMALE; HEART FAILURE; HEART FUNCTION; HEART MUSCLE REVASCULARIZATION; HEART VENTRICLE REMODELING; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; BLOOD; CLINICAL TRIAL; COMPLICATION; DOSE RESPONSE; DRUG EFFECT; ELECTROCARDIOGRAPHY; FOLLOW UP; METABOLISM; MORBIDITY; SURVIVAL RATE; TREATMENT OUTCOME; TRENDS; UNITED STATES;

ANTIRHEUMATIC AGENTS; C-REACTIVE PROTEIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ECHOCARDIOGRAPHY; ELECTROCARDIOGRAPHY; FEMALE; FOLLOW-UP STUDIES; HEART FAILURE; HUMANS; INTERLEUKIN 1 RECEPTOR ANTAGONIST PROTEIN; INTERLEUKIN-1; MALE; MIDDLE AGED; MORBIDITY; ST ELEVATION MYOCARDIAL INFARCTION; SURVIVAL RATE; TREATMENT OUTCOME; UNITED STATES; VENTRICULAR REMODELING;

EID: 85053213017     PISSN: 01609289     EISSN: 19328737     Source Type: Journal    
DOI: 10.1002/clc.22988     Document Type: Article

References (17)

1. Velagaleti RS, Pencina MJ, Murabito JM, et al. Long-term trends in the incidence of heart failure after myocardial infarction. Circulation. 2008;118:2057–2062.
2. Mezzaroma E, Toldo S, Farkas D, et al. The inflammasome promotes adverse cardiac remodeling following acute myocardial infarction in the mouse. Proc Natl Acad Sci U S A. 2011;108:19725–19730.
3. Roubille F, Samri A, Cornillet L, et al. Routinely-feasible multiple biomarkers score to predict prognosis after revascularized STEMI. Eur J Intern Med. 2010;21:131–136.
4. Seropian IM, Toldo S, Van Tassell BW, et al. Anti-inflammatory strategies for ventricular remodeling following ST-segment elevation acute myocardial infarction. J Am Coll Cardiol. 2014;63:1593–1603.
5. Abbate A, Van Tassell BW, Biondi-Zoccai GG. Blocking interleukin-1 as a novel therapeutic strategy for secondary prevention of cardiovascular events. BioDrugs. 2012;26:217–233.
6. Abbate A, Salloum FN, Vecile E, et al. Anakinra, a recombinant human interleukin-1 receptor antagonist, inhibits apoptosis in experimental acute myocardial infarction. Circulation. 2008;117:2670–2683.
7. Furst DE. Anakinra: review of recombinant human interleukin-I receptor antagonist in the treatment of rheumatoid arthritis. Clin Ther. 2004;26:1960–1975.
8. Abbate A, Kontos MC, Grizzard JD, et al. Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University–Anakinra Remodeling Trial [VCU-ART] pilot study). Am J Cardiol. 2010;105:1371.e1–1377.e1.
9. Abbate A, Van Tassell BW, Biondi-Zoccai G, et al. Effects of interleukin-1 blockade with anakinra on adverse cardiac remodeling and heart failure after acute myocardial infarction (from the Virginia Commonwealth University–Anakinra Remodeling Trial (2) [VCU-ART2] pilot study). Am J Cardiol. 2013;111:1394–1400.
10. Abbate A, Kontos MC, Abouzaki NA, et al. Comparative safety of interleukin-1 blockade with anakinra in patients with ST-segment elevation acute myocardial infarction (from the VCU-ART and VCU-ART2 pilot studies). Am J Cardiol. 2015;115:288–292.
11. Eapen ZJ, Tang WH, Felker GM, et al. Defining heart failure endpoints in ST-segment elevation myocardial infarction trials: integrating past experiences to chart a path forward. Circ Cardiovasc Qual Outcomes. 2012;5:594–600.
12. Van Tassell BW, Toldo S, Mezzaroma E, et al. Targeting interleukin-1 in heart disease. Circulation. 2013;128:1910–1923.
13. Ridker PM, Everett BM, Thuren T, et al; CANTOS Trial Group. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med. 2017;377:1119–1131.
14. Toldo S, Austin D, Mauro AG, et al. Low-density lipoprotein receptor–related protein-1 is a therapeutic target in acute myocardial infarction. JACC Basic Transl Sci. 2017;2:561–74. doi:https://doi.org/10.1016/j.jacbts.2017.05.007.
15. Mauro AG, Mezzaroma E, Torrado J, et al. Reduction of myocardial ischemia-reperfusion injury by inhibiting interleukin-1 alpha. J Cardiovasc Pharmacol. 2017;69:156–160.
16. Morton AC, Rothman AMK, Greenwood JP, et al. The effect of interleukin-1 receptor antagonist therapy on markers of inflammation in non-ST elevation acute coronary syndromes: the MRC-ILA Heart Study. Eur Heart J. 2015;36:377–384.
17. Ridker PM, MacFadyen JG, Everett BM, et al; CANTOS Trial Group. Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomised controlled trial. Lancet. 2018;391:319–328.