A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery

Study Overview
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Brief Summary
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High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.

Official Title
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A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery

Conditions
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Valvular Cardiac Surgery

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5. | Drug: Rosuvastatin<br>* Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.<br>* Other names: Rosuvastatin 40 mg/day;|
| Placebo Comparator: Placebo<br>Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5 | Drug: Placebo<br>* Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Inflammatory Markers | Significant (p<0.05) improvement of measured inflammatory markers | Within 5 days post-op and at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo | Within 3 months | 
| Stroke | Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo | Within 3 months | 
| Myocardial Infarction | Significant (p<0.05) reduction of MI events in rosuvastatin arm versus | Within 3 months | 
| ICU length of stay | Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo | 3 months |