MedTrace Logo

PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study

NCT02546648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-04-24

No results posted yet for this study

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.

Conditions

  • Atherosclerotic Disease
  • Perioperative Bleeding

Interventions

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.

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • James Khan, MD · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-10-31
Completion
2016-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02546648 on ClinicalTrials.gov