Atherosclerotic Disease Clinical Trial
— POISE-3Official title:
PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study (POISE-3)
Verified date | August 2017 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton General Hospital | Hamilton | Ontario |
Canada | Juravinski Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Hamilton Health Sciences Corporation, Population Health Research Institute |
Canada,
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. |
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