Condition category
Circulatory System
Date applied
19/08/2005
Date assigned
19/08/2005
Last edited
25/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.phri.ca/poise.htm

Contact information

Type

Scientific

Primary contact

Dr Philip Devereaux

ORCID ID

Contact details

Clinical Epidemiology & Biostatistics
McMaster University Health Sciences Centre
Room 2C8
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140 ext. 22063
philipj@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00182039

Protocol/serial number

MCT-50851, ACTRN012605000308695

Study information

Scientific title

Acronym

POISE

Study hypothesis

Perioperative metoprolol will reduce the 30 day risk of major cardiovascular events in patients undergoing noncardiac surgery.

Ethics approval

McMaster University Research Ethics Board approved on 25th April 2002

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Cardiovascular

Intervention

Patients will be randomly assigned to either the experimental intervention of oral metoprolol or the control intervention, a placebo. Patients will receive their first dose of metoprolol CR or placebo two to four hours pre-operatively at a strength of 100 mg (1/2 of a 200 mg tablet). Patients will then receive their second dose of their assigned intervention during the first 6 hours or at 6 hours post surgery. Twelve hours after the second post-op dose, patients will start taking a daily dose of 200 mg of either metoprolol CR or placebo for a duration of 30 days post surgery.

For further information, please contact Dr Devereaux at the address listed below or Dr Homer Yang at Ottawa Hospital (hyang@ottawahospital.on.ca).

Intervention type

Drug

Phase

Not Applicable

Drug names

Metoprolol

Primary outcome measures

Cardiac death at 30 days, nonfatal myocardial infarction (MI), and nonfatal cardiac arrest

Secondary outcome measures

1. Length of hospital stay
2. Length of stay in an ICU/CCU
3. Revascularisation procedures (i.e. coronary artery bypass surgery and percutaneous transluminal coronary angioplasty)
4. Pulmonary oedema
5. Clinically significant atrial fibrillation
6. Stroke
7. Total mortality
8. Rehospitalisation for cardiac reasons
9. Myocardial infarction
10. Nonfatal cardiac arrest
11. Cardiovascular mortality
12. Clinically significant hypotension
13. Clinically significant bradycardia

Overall trial start date

01/09/2002

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Greater than or equal to 45 years of age, either sex
2. Have an expected length of stay greater than or equal to 24 hours
3. Fulfill any one of the following six criteria:
3.1. Coronary artery disease
3.2. Peripheral vascular disease
3.3. History of stroke due to atherothrombotic disease
3.4. Hospitalisation for congestive heart failure within 3 years of randomisation
3.5. Undergoing major vascular surgery
3.6. Any three of the following seven criteria: scheduled for high risk surgery (i.e. intraperitoneal or intrathoracic), emergency/urgent surgery, any history of congestive heart failure, history of a transient ischaemic attack (TIA), diabetes and currently on an oral hypoglycaemic agent or insulin therapy, preoperative serum creatinine greater than 175 µmol/l (greater than 2.0 mg/dl), or age greater than 70 years
4. Are able to give written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10,000

Participant exclusion criteria

1. Contradiction to metoprolol including any of the following: significant bradycardia (heart rate less than 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
2. Clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days
prior adverse reaction to a beta-blocker
3. Coronary artery bypass graft (CABG) surgery with complete revascularisation in the preceding 5 years and no evidence of cardiac ischaemia since the CABG surgery
4. Patients undergoing low risk surgical procedures (potential examples include transurethral procedures [transurethral prostatectomies {TURPs}, stone baskets etc.], ophthalmologic procedures under topical or regional anaesthesia [cornea transplants, cataract surgery etc.], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs etc.])
5. Concurrent use of verapamil
6. Prior enrolment in this trial

Recruitment start date

01/09/2002

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Australia, Canada

Trial participating centre

Clinical Epidemiology & Biostatistics
Hamilton, Ontario
L8N 3Z5
Canada

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

1200 Main Street West
Hamilton
Ontario
L8N3Z5
Canada
+1 905 521 2100 ext 22465
townsend@mcmaster.ca

Sponsor type

University/education

Website

http://www.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50851)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Health and Medical Research Council (NHMRC) (Australia)

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Funder name

Australia Clinical Trials Grant (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Astra Zeneca (International)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18479744

Publication citations

  1. Results

    , 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, Málaga 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, 371, 9627, 1839-1847, doi: 10.1016/S0140-6736(08)60601-7.

Additional files

Editorial Notes