POISE Trial: Perioperative Ischemic Evaluation Study

• Status: Terminated
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborators: AstraZeneca; British Heart Foundation; Canadian Institutes of Health Research (CIHR); National Health and Medical Research Council, Australia
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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