Status:
TERMINATED
POISE Trial: Perioperative Ischemic Evaluation Study
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 postoperative days
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
8351 Patients enrolled
Trial Details
Trial ID
NCT00182039
Start Date
October 1 2002
End Date
August 1 2007
Last Update
April 11 2008
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5