Completed

NCT Number: NCT01425398

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

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

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Key information

Conditions

Valvular Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.

Other names: Rosuvastatin 40 mg/day

Placebo

Drug

Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5.

Primary outcomes

Improved Inflammatory Markers

Time frame: Within 5 days post-op and at 3 months

Significant (p<0.05) improvement of measured inflammatory markers

Secondary outcomes

Mortality

Time frame: Within 3 months

Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo
Stroke

Time frame: Within 3 months

Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo
Myocardial Infarction

Time frame: Within 3 months

Significant (p<0.05) reduction of MI events in rosuvastatin arm versus
ICU length of stay

Time frame: 3 months

Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Aug 30, 2011
Registry last updated: Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.