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

Phase 3

Completed

• Conditions: Valvular Cardiac Surgery
• Interventions: Drug: Placebo; Drug: Rosuvastatin

• Registration Number: NCT01425398
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Study Start: 2011-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5
Rosuvastatin	Rosuvastatin	Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.

Primary Outcome Measures

Name	Time	Method
Improved Inflammatory Markers	Within 5 days post-op and at 3 months	Significant (p\<0.05) improvement of measured inflammatory markers

Secondary Outcome Measures

Name	Time	Method
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
ICU length of stay	3 months	Significant reduction (p\<0.05) of length of stay in rosuvastatin arm versus placebo
Myocardial Infarction	Within 3 months	Significant (p\<0.05) reduction of MI events in rosuvastatin arm versus

Trial Locations

Locations (1)

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada