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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Treatments: Rosuvastatin Calcium

Criteria

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