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

McGill University

Status and phase

Completed

Phase 3

Conditions

Valvular Cardiac Surgery

Treatments

Drug: Rosuvastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01425398

statins_inflammation_CVsurgery

Details and patient eligibility

About

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

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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