An open-label, non-inferiority randomized controlled trial of lidocAine Versus Opioids In MyocarDial Infarction study (AVOID-2 study) methods paper.

Abstract

Background There is increasing evidence that opioids interfere with the oral bioavailability of P2Y12 inhibitors leading to delayed onset of antiplatelet effects. Several strategies have been proposed to mitigate this interaction including utilizing alternative analgesic agents in the management of ischemic chest pain. Methods The lidocAine Versus Opioids In MyocarDial Infarction (AVOID-2) study is a phase II, pre-hospital, open-label, non-inferiority, randomized controlled trial conducted by Ambulance Victoria and Monash University in metropolitan Melbourne, Victoria, Australia. The purpose of the study is to compare the analgesic effect (reduction in pain by arrival to hospital) and safety (e.g. adverse drug reactions) (co-primary endpoints) of intravenous lidocaine versus intravenous fentanyl in 300 adult patients attended by ambulance with suspected ST-elevation myocardial infarction (STEMI). Secondary endpoints and a cardiac magnetic resonance imaging (MRI) sub-study will also compare infarct size between these two groups. Conclusions The evaluation of alternative analgesic agents in the management of acute coronary syndromes is urgently needed to manage the opioid-P2Y12 inhibitor interaction. The results of this trial will have significant implications on the emergency management of acute coronary syndromes internationally.

• Authors: Himawan Fernando, Catherine Milne, Ziad Nehme, Jocasta Ball, Stephen Bernard, Michael Stephenson, Paul S Myles, Janet E Bray, Jeffrey Lefkovits, Danny Liew, Karlheinz Peter, Angela Brennan, Diem Dinh, Emily Andrew, Andrew J Taylor, Karen Smith, Dion Stub
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 105 Pg. 106411 (06 2021) ISSN: 1559-2030 [Electronic] United States
• PMID: 33894363 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 Elsevier Inc. All rights reserved.

Chemical References

• Analgesics, Opioid
• Lidocaine

Topics

• Acute Coronary Syndrome (drug therapy)
• Adult
• Analgesics, Opioid (therapeutic use)
• Humans
• Lidocaine
• Myocardial Infarction (drug therapy)
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• Treatment Outcome