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

Valvular Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425398
• Other study ID #: statins_inflammation_CVsurgery
• Status: Completed
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Valvular Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved Inflammatory Markers	Significant (p<0.05) improvement of measured inflammatory markers	Within 5 days post-op and at 3 months
Secondary	Mortality	Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo	Within 3 months
Secondary	Stroke	Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo	Within 3 months
Secondary	Myocardial Infarction	Significant (p<0.05) reduction of MI events in rosuvastatin arm versus	Within 3 months
Secondary	ICU length of stay	Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo	3 months