Status:
COMPLETED
A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Valvular Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.
Eligibility Criteria
Inclusion
- Single or multiple valve repairs or replacements without coronary artery bypass grafting
- Bentall procedure, but no other aortic procedures
- With or without accompanying MAZE procedure (surgical treatment for atrial fibrillation)
Exclusion
- Age under 18 years old
- Urgent or emergency surgery
- Unable to provide consent
- Presently on statin therapy or exposure to statins within a month of surgery
- Chronic anti-inflammatory use, including steroids and NSAID's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period)
- Known hypersensitivity to rosuvastatin
- Active liver disease Indicated by AST/ALT higher than 3 times the upper limit of normal
- Pregnant or nursing women
- On drugs with interactions (Cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir, niacin) Severe renal impairment not on dialysis
- Creatinine clearance \< 30 ml/min/1.73 m2
- Known myopathy and inflammatory diasthesis (such as systemic lupus erythromatosus, rheumatoid arthritis, and inflammatory bowel disease)
- Human Immunodeficiency Virus
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01425398
Start Date
November 1 2011
End Date
December 1 2013
Last Update
October 21 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1