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

Sponsor
McMaster University (Other)
Overall Status
Completed
CT.gov ID
NCT02546648
Collaborator
Population Health Research Institute (Other), Hamilton Health Sciences Corporation (Other)
100
Enrollment
2
Locations
2
Arms
18
Duration (Months)
50
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid
  • Drug: Tranexamic Acid Placebo
  • Drug: Rosuvastatin or matching placebo
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study (POISE-3)
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tranexamic Acid vs. matching placebo

Tranexamic Acid 1g bolus with anesthesia induction followed by 1g bolus at the start of surgical closure.

Drug: Tranexamic Acid
Other Names:
  • Cyklokapron

    • Drug: Tranexamic Acid Placebo
    Experimental: Rosuvastatin vs. matching placebo

    Rosuvastatin 20 mg orally or matching placebo once per day until 30 days after surgery

    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.
    Other Names:
  • Crestor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative intervention discontinuation [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 [Postoperative day 1.]

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

    Secondary Outcome Measures

    1. All-cause mortality [Postoperative day 30.]

    2. Non-fatal myocardial infarction [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. [Postoperative day 30.]

      Event composite

    Other Outcome Measures

    1. Safety Outcomes for Rosuvastatin assessed by Statin induced myopathy [Postoperative day 30.]

    2. Safety Outcomes for Tranexamic Acid assessed by Seizure, pulmonary emboli, deep venous thrombosis, vascular mortality [Postoperative day 30.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. undergoing noncardiac surgery

    2. 45 years of age

    3. expected to require at least an overnight hospital admission after surgery; AND

    4. have a preoperative NT-pro-BNP measurement >100 ng/mL; OR

    5. 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:

    1. planned use of systemic Tranexamic Acid during surgery

    2. hypersensitivity or known allergy to TXA

    3. creatinine clearance <30 mL/min (MDRD)

    4. history of seizure disorder

    5. history of venous thromboembolism

    6. acute arterial thrombosis

    7. no preoperative measurement of hemoglobin

    8. subarachnoid hemorrhage within the past 30 days

    9. hematuria caused by diseases of the renal parenchyma

    10. previously enrolled in POISE-3 pilot trial

    11. 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:

    1. preoperative treatment with a statin or a non statin lipid lowering drug or ciclosporin during the 48 hours before surgery

    2. hypersensitivity or known allergy to Rosuvastatin

    3. pre-disposed factors for myopathy or rhabdomyolysis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamilton General Hospital Hamilton Ontario Canada L8L 2X2
    2 Juravinski Hospital Hamilton Ontario Canada L8V 1C3

    Sponsors and Collaborators

    • McMaster University
    • Population Health Research Institute
    • Hamilton Health Sciences Corporation

    Investigators

    • Study Chair: James Khan, MD, Hamilton Health Sciences Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    McMaster University
    ClinicalTrials.gov Identifier:
    NCT02546648
    Other Study ID Numbers:
    • POISE3034
    First Posted:
    Sep 11, 2015
    Last Update Posted:
    Apr 24, 2018
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Tranexamic Acid
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Apr 24, 2018