Valvular Cardiac Surgery
Conditions
Brief summary
High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.
Interventions
DRUGRosuvastatin
Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
DRUGPlacebo
Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved Inflammatory Markers | Within 5 days post-op and at 3 months | Significant (p\<0.05) improvement of measured inflammatory markers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Within 3 months | Significant (p\<0.05) reduction of mortality in rosuvastatin arm versus placebo |
| Stroke | Within 3 months | Significant (p\<0.05) reduction of stroke events in rosuvastatin arm versus placebo |
| Myocardial Infarction | Within 3 months | Significant (p\<0.05) reduction of MI events in rosuvastatin arm versus |
| ICU length of stay | 3 months | Significant reduction (p\<0.05) of length of stay in rosuvastatin arm versus placebo |
Countries
Canada
Outcome results
None listed