PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University; Population Health Research Institute
• Collaborators: Hamilton Health Sciences Corporation; Population Health Research Institute
• Treatments: Rosuvastatin Calcium; Tranexamic Acid

Criteria

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