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Research

Photo for POISE - 2

POISE - 2

Official Title

Perioperative Ischemic Evaluation-2 Trial

Status

Ongoing

Overview

To determine the impact of clonidine versus placebo and ASA versus placebo on the 30-day risk of all-cause mortality or nonfatal myocardial infarction in patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Patients in the POISE-2 trial will be randomly assigned to one of four groups: ASA and Clonidine together, ASA and Clonidine placebo, ASA placebo and Clonidine, or a ASA placebo and Clonidine placebo. Research personnel will follow patients at 30 days post-randomization and 1 year post-randomization.

Study Design

Randomized, double-blind, placebo control, factorial assignment, safety/efficacy study.

Primary Endpoint

Composite of all-cause mortality and nonfatal MI at 30 days after randomization

Number of Patients

10010

Number of Sites

135

Number of Countries

23

Study Period

2010–2015

Principal Investigator

P.J. Devereaux

Program Manager

Susan Chrolavicius, Shirley Pettit

Research Coordinator

Andrea Robinson

Key Publications

  • Devereaux et al. Aspirin in Patients Undergoing Noncardiac Surgery. New England Journal of Medicine 2014 Apr 17;370(16):1494-503.
  • Devereaux et al. Clonidine in Patients Undergoing Noncardiac Surgery. New England Journal of Medicine 2014 Apr 17;370(16):1504-13.
  • Devereaux et al. Rationale and design of the PeriOperative ISchemic Evaluation-2 (POISE-2) Trial: An international 2 X 2 factorial randomized controlled trial of acetyl-salicylic acid versus placebo and clonidine versus placebo in patients undergoing noncardiac surgery. American Heart Journal 2014 Jun;167(6):804-809.e4.
  • Garg et al. Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial. British Medical Journal Open. 2014 Feb 25;4(2):e004886.