Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02546648
Other study ID # POISE3034
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A
Recruiting NCT03480568 - Alirocumab in Patients on a Stable Dialysis Regimen Phase 3
Recruiting NCT02176941 - Telomeres and Arterial Aging N/A
Completed NCT00673985 - Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study N/A
Completed NCT00090168 - Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(COMPLETED) Phase 3
Completed NCT00738725 - BioImage Study: A Clinical Study of Burden of Atherosclerotic Disease in an At-Risk Population N/A
Completed NCT00352222 - Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries Phase 3
Completed NCT02462005 - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.