PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study

Atherosclerotic Disease Clinical Trial

— POISE-3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546648
• Other study ID #: POISE3034
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2015
• Last updated: April 20, 2018
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerotic Disease
• Perioperative Bleeding

Intervention

Drug:
• Tranexamic Acid

• Tranexamic Acid Placebo

• 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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcomes for Rosuvastatin assessed by Statin induced myopathy		Postoperative day 30.
Other	Safety Outcomes for Tranexamic Acid assessed by Seizure, pulmonary emboli, deep venous thrombosis, vascular mortality	myocardial infarction, stroke, non-fatal cardiac arrest, and cardiac revascularization procedure.	Postoperative day 30.
Primary	Postoperative intervention discontinuation	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.	Postoperative day 1 to 30.
Primary	Change in hemoglobin	Change in preoperative hemoglobin to the morning hemoglobin recorded on day 1 after surgery.	Postoperative day 1.
Secondary	All-cause mortality		Postoperative day 30.
Secondary	Non-fatal myocardial infarction		Postoperative day 30.
Secondary	A composite of vascular mortality and non-fatal: myocardial infarction, stroke, cardiac arrest, pulmonary embolus, deep venous thrombosis, life threatening bleeding, major bleeding.	Event composite	Postoperative day 30.