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POISE Trial: Perioperative Ischemic Evaluation Study (POISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00182039
Recruitment Status : Terminated (Please see detailed description for reason why study was terminated.)
First Posted : September 16, 2005
Last Update Posted : April 11, 2008
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
British Heart Foundation
AstraZeneca
Information provided by:
McMaster University

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date April 11, 2008
Study Start Date  ICMJE October 2002
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
  • clinically significant atrial fibrillation rehospitalization for cardiac reasons [ Time Frame: 30 days and 1 year ]
  • nonfatal myocardial infarction [ Time Frame: 30 days and 1 year ]
  • nonfatal cardiac arrest [ Time Frame: 30 days and 1 year ]
  • cardiovascular death [ Time Frame: 30 days and 1 year ]
  • total mortality [ Time Frame: 30 days and 1 year ]
  • revascularization procedures (i.e. coronary artery bypass surgery and percutaneous transluminal coronary angioplasty) [ Time Frame: 30 days and 1 year ]
  • congestive heart failure [ Time Frame: 30 days and 1 year ]
  • clinically significant bradycardia [ Time Frame: 30 days ]
  • clinically significant hypotension [ Time Frame: 30 days ]
  • nonfatal stroke [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE POISE Trial: Perioperative Ischemic Evaluation Study
Official Title  ICMJE Perioperative Ischemic Evaluation Study (POISE) Trial
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: A
    metoprolol
    Intervention: Drug: Metoprolol controlled release (CR)
  • Placebo Comparator: B
    placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2008)
8351
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
10000
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00182039
Other Study ID Numbers  ICMJE MCT-50851-CT
ISRCTN17233551
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. P.J. Devereaux, McMaster University
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • National Health and Medical Research Council, Australia
  • British Heart Foundation
  • AstraZeneca
Investigators  ICMJE
Principal Investigator: P.J. Devereaux, MD McMaster University
Principal Investigator: Homer Yang, MD University of Ottawa
PRS Account McMaster University
Verification Date January 2008

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