POISE Trial: Perioperative Ischemic Evaluation Study
Information source: Hamilton Health Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases
Intervention: Metoprolol controlled release (CR) (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Hamilton Health Sciences
Official(s) and/or principal investigator(s):
P.J. Devereaux, MD, Principal Investigator, Affiliation: Hamilton Health Sciences
Homer Yang, MD, Principal Investigator, Affiliation: University of Ottawa
This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart
attacks and deaths around the time of surgery.
Official title: Perioperative Ischemic Evaluation Study (POISE) Trial
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest)
clinically significant atrial fibrillation rehospitalization for cardiac reasons
nonfatal myocardial infarction
nonfatal cardiac arrest
revascularization procedures (i.e. coronary artery bypass surgery and percutaneous transluminal coronary angioplasty)
congestive heart failure
clinically significant bradycardia
clinically significant hypotension
The POISE Trial is a large multi-centre, blinded, randomized controlled group trial of
metoprolol vs placebo in 10,000 at risk patients undergoing noncardiac surgery. The POISE
Trial will determine the impact of perioperative administration of metoprolol on
cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or
nonfatal cardiac arrest) during the 30 day post-operative period in at risk patients
undergoing noncardiac surgery.
Assuming a control group event rate of 6% for our primary outcome, we determined
randomization of 8000 patients would provide 85% power and 10,000 patients 92% power to
detect a relative risk reduction of 25% (two-sided alpha = 0. 05). We set a goal to randomize
10,000 patients recognizing that we would have adequate power if we randomized 8000 patients.
Without knowledge of the trial results and knowing that we had randomized more than 8000
patients and had a higher than predicted event rate, the Operations Committee decided to
terminate recruitment on July 31, 2007 primarily because the remaining study drug expired in
Minimum age: 45 Years.
Maximum age: N/A.
- Patients undergoing noncardiac surgery
- ≥ 45 years of age; either sex.
- Have an expected length of stay ≥ 24 hours
- Fulfill any one of the following 6 criteria:
- coronary artery disease;
- peripheral vascular disease;
- history of stroke due to atherothrombotic disease;
- hospitalization for congestive heart failure within 3 years of randomization;
- undergoing major vascular surgery; OR
- any 3 of the following 7 criteria: scheduled for high risk surgery (i. e.
intraperitoneal or intrathoracic); emergency/urgent surgery; any history of
congestive heart failure; history of a transient ischemic attack (TIA); diabetes
and currently on an oral hypoglycemic agent or insulin therapy; preoperative
serum creatinine > 175 µmol/L (> 2. 0 mg/dl); or age > 70 years.
- Contraindication to metoprolol including any of the following: significant bradycardia
(heart rate < 50 beats per minute); second or third degree heart block without a
pacemaker; asthma that has been active within the last decade; and history of chronic
obstructive pulmonary disease (COPD) with bronchospasm on pulmonary function tests.
- Clinical plan to use a beta-blocker preoperatively or during the first 30
- Prior adverse reaction to a beta-blocker
- Coronary artery bypass graft (CABG) surgery with complete revascularization in the
preceding 5 years and no evidence of cardiac ischemia since the CABG surgery
- Patients undergoing low risk surgical procedures (potential examples include
transurethral procedures [transurethral prostatectomies (TURPs), stone baskets, etc.],
ophthalmologic procedures under topical or regional anesthesia [cornea transplants,
cataract surgery, etc.], and surgeries with limited physiological stresses [digital
re-implantation, nerve repairs, etc.] )
- Concurrent use of verapamil
- Prior enrollment in this trial
Locations and Contacts
McMaster University, Hamilton, Ontario L8N 3Z5, Canada
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 Aug;152(2):223-30.
Starting date: October 2002
Ending date: August 2007
Last updated: April 10, 2008