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Research

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POISE

Official Title

Perioperative Ischemic Evaluation Study (POISE) Trial

Status

Completed

Overview

To evaluate the effects of metoprolol (a beta-blocker drug) on the prevention heart attacks and deaths around the time of noncardiac surgery. POISE is one of the largest trials in perioperative medicine and has had a significant impact on guidelines and patterns of practice.

Study Design

Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), placebo control, parallel group design, efficacy study.

Primary Endpoint

Major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest); Secondary endpoints: Clinically significant atrial fibrillation re-hospitalization for cardiac reasons. Nonfatal myocardial infarction. Nonfatal cardiac arrest. Cardiovascular death. Total mortality. Revascularization procedures (i.e. coronary artery bypass surgery and percutaneous transluminal coronary angioplasty). Congestive heart failure. Clinically significant bradycardia. Clinically significant hypotension. Nonfatal stroke. All primary and secondary events were adjudicated.

Number of Patients

8351

Number of Sites

190

Number of Countries

23

Study Period

2002–2007

Principal Investigator

P.J. Devereaux

Program Manager

Susan Chrolavicius

Research Coordinator

Launi Greenspan

Key Publications

  • POISE Trial Investigators, Devereaux PJ, Yang H, Guyatt GH, Leslie K, Villar JC, Monteri VM, Choi P, Giles JW, Yusuf S. Rationale, design, and organization of the PeriOperative ISchemic Evaluation (POISE) trial: a randomized controlled trial of metoprolol versus placebo in patients undergoing noncardiac surgery. Am Heart J. 2006;152(2):223-30.
  • POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Málaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P.. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomized controlled trial. Lancet 2008; 371: 1839-47.