Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
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
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18479744
Publication citations
-
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.