POISE Trial: Perioperative Ischemic Evaluation Study

NCT00182039 | Terminated Phase 3 DMC

• 2 other identifiers: MCT-50851-CTISRCTN17233551
• Study Type: interventional
• Target: 8,351
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

randomized controlled trial; blinded; noncardiac surgery; cardiovascular events

Outcome Measures

Primary Outcomes (1)

• major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest)

  30 days

Secondary Outcomes (10)

• clinically significant atrial fibrillation rehospitalization for cardiac reasons

  30 days and 1 year

• nonfatal myocardial infarction

  30 days and 1 year

• nonfatal cardiac arrest

  30 days and 1 year

• cardiovascular death

  30 days and 1 year

• total mortality

  30 days and 1 year

Study Arms (2)

A

EXPERIMENTAL

metoprolol

Drug: Metoprolol controlled release (CR)

B

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Metoprolol controlled release (CR) DRUG

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.

A

Placebo DRUG

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.

B

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• National Health and Medical Research Council, Australia: collaborator
• British Heart Foundation: collaborator
• AstraZeneca: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (3)

• 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. doi: 10.1016/j.ahj.2006.05.019.

  PMID: 16875901 BACKGROUND

• Devereaux PJ, Xavier D, Pogue J, Guyatt G, Sigamani A, Garutti I, Leslie K, Rao-Melacini P, Chrolavicius S, Yang H, Macdonald C, Avezum A, Lanthier L, Hu W, Yusuf S; POISE (PeriOperative ISchemic Evaluation) Investigators. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: a cohort study. Ann Intern Med. 2011 Apr 19;154(8):523-8. doi: 10.7326/0003-4819-154-8-201104190-00003.

  PMID: 21502650 DERIVED

• POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.

  PMID: 18479744 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• P.J. Devereaux, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Homer Yang, MD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2002
• Primary Completion: July 1, 2007
• Study Completion: August 1, 2007
• Last Updated: April 11, 2008

Record last verified: 2008-01

Locations

CA (1)