A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Ca… (NCT01425398) | Clinical Trial Compass
CompletedPhase 3
A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
Canada170 participantsStarted 2011-11
Plain-language summary
High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improved Inflammatory Markers
Timeframe: Within 5 days post-op and at 3 months
Trial details
NCT IDNCT01425398
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre