drugset / Trial / NCT01950299
Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)
Phase 2/3
Completed
99 enrolled
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2014-07-01
- Primary completion
- 2018-12-23
- Completion
- 2018-12-23
Publications
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | — |