POISE Trial: Perioperative Ischemic Evaluation Study

PHASE3TerminatedINTERVENTIONAL
Enrollment

8,351

Participants

Timeline

Start Date

October 31, 2002

Primary Completion Date

July 31, 2007

Study Completion Date

August 31, 2007

Conditions
Cardiovascular Diseases
Interventions
DRUG

Metoprolol controlled release (CR)

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.

DRUG

Placebo

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.

Trial Locations (1)

L8N 3Z5

McMaster University, Hamilton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

National Health and Medical Research Council, Australia

OTHER

collaborator

British Heart Foundation

OTHER

collaborator

AstraZeneca

INDUSTRY

lead

Hamilton Health Sciences Corporation

OTHER