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POISE Trial: Perioperative Ischemic Evaluation Study

This study has been terminated.
(Please see detailed description for reason why study was terminated.)
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
British Heart Foundation
AstraZeneca
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182039
First received: September 9, 2005
Last updated: April 10, 2008
Last verified: January 2008

September 9, 2005
April 10, 2008
October 2002
July 2007   (final data collection date for primary outcome measure)
major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest)
Complete list of historical versions of study NCT00182039 on ClinicalTrials.gov Archive Site
  • clinically significant atrial fibrillation rehospitalization for cardiac reasons [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • nonfatal myocardial infarction [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • nonfatal cardiac arrest [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • cardiovascular death [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • total mortality [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • revascularization procedures (i.e. coronary artery bypass surgery and percutaneous transluminal coronary angioplasty) [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • congestive heart failure [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
  • clinically significant bradycardia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • clinically significant hypotension [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • nonfatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • clinically significant atrial fibrillation rehospitalization 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
Not Provided
Not Provided
 
POISE Trial: Perioperative Ischemic Evaluation Study
Perioperative Ischemic Evaluation Study (POISE) Trial

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

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 September 2007.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Drug: Metoprolol controlled release (CR)
    Patients received the first dose of the study drug (i.e., oral metoprolol CR or matching placebo 100 mg) 2-4 hours prior to surgery. Administration of the study drug at each dosing time required a patient to have a heart rate ≥ 50 beats per minute (bpm) and a systolic blood pressure (SBP) ≥ 100 mmHg. If the patient's heart rate was ≥ 80 bpm and their SBP ≥ 100 mmHg at any time during the first 6 hours after surgery, the patient received their first postoperative dose (i.e., 100 mg of the study drug) orally. Patients who did not receive the study drug during the first 6 hours after surgery received 100 mg of the study drug orally at 6 hours after surgery. Twelve hours after the first postoperative dose patients started taking oral metoprolol CR or placebo 200 mg daily for 30 days.
  • Drug: Placebo
    Patients received the first dose of the study drug (i.e., oral metoprolol CR or matching placebo 100 mg) 2-4 hours prior to surgery. Administration of the study drug at each dosing time required a patient to have a heart rate ≥ 50 beats per minute (bpm) and a systolic blood pressure (SBP) ≥ 100 mmHg. If the patient's heart rate was ≥ 80 bpm and their SBP ≥ 100 mmHg at any time during the first 6 hours after surgery, the patient received their first postoperative dose (i.e., 100 mg of the study drug) orally. Patients who did not receive the study drug during the first 6 hours after surgery received 100 mg of the study drug orally at 6 hours after surgery. Twelve hours after the first postoperative dose patients started taking oral metoprolol CR or placebo 200 mg daily for 30 days.
  • Experimental: A
    metoprolol
    Intervention: Drug: Metoprolol controlled release (CR)
  • Placebo Comparator: B
    placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8351
August 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00182039
MCT-50851-CT, ISRCTN17233551
Yes
Dr. P.J. Devereaux, McMaster University
Hamilton Health Sciences Corporation
  • Canadian Institutes of Health Research (CIHR)
  • National Health and Medical Research Council, Australia
  • British Heart Foundation
  • AstraZeneca
Principal Investigator: P.J. Devereaux, MD McMaster University
Principal Investigator: Homer Yang, MD University of Ottawa
McMaster University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP