Perioperative ischemic evaluation study (POISE study)
| ISRCTN | ISRCTN17233551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17233551 |
| ClinicalTrials.gov number | NCT00182039 |
| Secondary identifying numbers | MCT-50851, ACTRN012605000308695 |
- Submission date
- 19/08/2005
- Registration date
- 19/08/2005
- Last edited
- 25/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Devereaux
Scientific
Scientific
Clinical Epidemiology & Biostatistics
McMaster University Health Sciences Centre
Room 2C8, 1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 525 9140 ext. 22063 |
|---|---|
| philipj@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | |
| Study acronym | POISE |
| Study objectives | Perioperative metoprolol will reduce the 30 day risk of major cardiovascular events in patients undergoing noncardiac surgery. |
| Ethics approval(s) | McMaster University Research Ethics Board approved on 25th April 2002 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2002 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10,000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Australia
- Canada
Study participating centre
Clinical Epidemiology & Biostatistics
Hamilton, Ontario
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
1200 Main Street West
Hamilton, Ontario
L8N3Z5
Canada
| Phone | +1 905 521 2100 ext 22465 |
|---|---|
| townsend@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50851)
No information available
National Health and Medical Research Council (NHMRC) (Australia)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Australia Clinical Trials Grant (Australia)
No information available
British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Astra Zeneca (International)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/05/2008 | Yes | No |
