NCT02546648

PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study

PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study (POISE-3)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.

Detailed description

The POISE-3 pilot is a randomized controlled trial of 100 patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Utilizing a partial factorial design, the POISE-3 pilot will determine the effect of rosuvastatin versus placebo and TXA versus placebo in the perioperative setting.

Conditions

• Atherosclerotic Disease
• Perioperative Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic Acid
DRUG	Tranexamic Acid Placebo
DRUG	Rosuvastatin or matching placebo	Subjects who are not on a statin will also be randomized to Rosuvastatin or Rosuvastatin placebo. 40mg preoperatively, followed by 20mg postoperatively (4-6 hours after surgical close) and 20mg/day for 30 days postoperatively.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-10-01
• Completion: 2016-08-01
• First posted: 2015-09-11
• Last updated: 2018-04-24

Locations

2 sites across 1 country: Canada