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Perioperative ischemic evaluation study (POISE study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17233551
Enrollment
10000
Registered
2005-08-19
Start date
2002-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Circulatory System

Interventions

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

Sponsors

McMaster University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Australia, Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026