Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182039
Status:
TERMINATED
Last Update Posted:
2008-04-11
First Post:
2005-09-09
Brief Title:
POISE Trial Perioperative Ischemic Evaluation Study
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Perioperative Ischemic Evaluation Study POISE Trial
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Please see detailed description for reason why study was terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POISE
Brief Summary:
This trial will evaluate the ability of metoprolol a beta-blocker drug to prevent heart attacks and deaths around the time of surgery
Detailed Description:
The POISE Trial is a large multi-centre blinded randomized controlled group trial of metoprolol vs placebo in 10000 at risk patients undergoing noncardiac surgery The POISE Trial will determine the impact of perioperative administration of metoprolol on cardiovascular events defined as cardiovascular death nonfatal myocardial infarction or nonfatal cardiac arrest during the 30 day post-operative period in at risk patients undergoing noncardiac surgery
Assuming a control group event rate of 6 for our primary outcome we determined randomization of 8000 patients would provide 85 power and 10000 patients 92 power to detect a relative risk reduction of 25 two-sided alpha 005 We set a goal to randomize 10000 patients recognizing that we would have adequate power if we randomized 8000 patients Without knowledge of the trial results and knowing that we had randomized more than 8000 patients and had a higher than predicted event rate the Operations Committee decided to terminate recruitment on July 31 2007 primarily because the remaining study drug expired in September 2007
Assuming a control group event rate of 6 for our primary outcome we determined randomization of 8000 patients would provide 85 power and 10000 patients 92 power to detect a relative risk reduction of 25 two-sided alpha 005 We set a goal to randomize 10000 patients recognizing that we would have adequate power if we randomized 8000 patients Without knowledge of the trial results and knowing that we had randomized more than 8000 patients and had a higher than predicted event rate the Operations Committee decided to terminate recruitment on July 31 2007 primarily because the remaining study drug expired in September 2007
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN17233551 | None | None | None |