Skip to main content
OpenTrials
Completed

NCT Number: NCT02546648

PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerotic Disease Perioperative Bleeding

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing noncardiac surgery
  • >45 years of age
  • expected to require at least an overnight hospital admission after surgery; AND
  • have a preoperative NT-pro-BNP measurement >100 ng/mL; OR
  • if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill 1 or more of the following 5 criteria:
  • history of coronary artery disease
  • history of peripheral vascular disease
  • history of stroke
  • undergoing major vascular surgery
  • have any 3 of the following 9 risk criteria:
  • undergoing major surgery
  • history of congestive heart failure
  • history of a transient ischemic attack
  • diabetic and currently taking an oral hypoglycemic agent or insulin
  • age >70 years
  • hypertension
  • serum creatinine > 175 umol/L (>2.0 mg/dl)
  • history of smoking within 2 years of surgery
  • undergoing emergent/urgent surgery

Exclusion criteria

  • planned use of systemic Tranexamic Acid during surgery
  • hypersensitivity or known allergy to TXA
  • creatinine clearance <30 mL/min (MDRD)
  • history of seizure disorder
  • history of venous thromboembolism
  • acute arterial thrombosis
  • no preoperative measurement of hemoglobin
  • subarachnoid hemorrhage within the past 30 days
  • hematuria caused by diseases of the renal parenchyma
  • previously enrolled in POISE-3 pilot trial
  • not consenting to participate in POISE-3 pilot trial prior to surgery

Patients meeting any of the following criteria will be excluded from the Rosuvastatin/Placebo arm:

  • preoperative treatment with a statin or a non statin lipid lowering drug or ciclosporin during the 48 hours before surgery
  • hypersensitivity or known allergy to Rosuvastatin
  • pre-disposed factors for myopathy or rhabdomyolysis

Treatment and study plan

Tranexamic Acid

Drug

Other names: Cyklokapron

Tranexamic Acid Placebo

Drug

Rosuvastatin or matching placebo

Drug

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.

Other names: Crestor

Primary outcomes

  1. Postoperative intervention discontinuation

    Time frame: Postoperative day 1 to 30.

    Interruption of the intervention longer than 24 hours within the first 10 days postoperatively, and longer than 48 hours from postoperative day 10 to 30.

  2. Change in hemoglobin

    Time frame: Postoperative day 1.

    Change in preoperative hemoglobin to the morning hemoglobin recorded on day 1 after surgery.

Secondary outcomes

  1. All-cause mortality

    Time frame: Postoperative day 30.

  2. Non-fatal myocardial infarction

    Time frame: Postoperative day 30.

  3. A composite of vascular mortality and non-fatal: myocardial infarction, stroke, cardiac arrest, pulmonary embolus, deep venous thrombosis, life threatening bleeding, major bleeding.

    Time frame: Postoperative day 30.

    Event composite

Other outcomes

  1. Safety Outcomes for Rosuvastatin assessed by Statin induced myopathy

    Time frame: Postoperative day 30.

  2. Safety Outcomes for Tranexamic Acid assessed by Seizure, pulmonary emboli, deep venous thrombosis, vascular mortality

    Time frame: Postoperative day 30.

    myocardial infarction, stroke, non-fatal cardiac arrest, and cardiac revascularization procedure.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • Population Health Research Institute

Registry information

Official study title

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

Acronym: POISE-3

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 11, 2015
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.