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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425398
Recruitment Status : Unknown
Verified August 2011 by Jacques Genest, McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2011
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):
Jacques Genest, McGill University Health Center

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

Condition or disease Intervention/treatment Phase
Valvular Cardiac Surgery Drug: Rosuvastatin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
Study Start Date : November 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rosuvastatin Drug: Rosuvastatin
Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
Placebo Comparator: Placebo Drug: Placebo
Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5.

Primary Outcome Measures :
  1. Improved Inflammatory Markers [ Time Frame: Within 5 days post-op and at 3 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Within 3 months ]
  2. Stroke [ Time Frame: Within 3 months ]
  3. Myocardial Infarction [ Time Frame: Within 3 months ]
  4. ICU length of stay [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01425398

Canada, Quebec
Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Jennifer Chung, M.D.    438-886-3901   
Principal Investigator: Jennifer Chung, M.D.         
Principal Investigator: Benoit De Varennes, M.D.         
Principal Investigator: Jacques Genest, M.D.         
Sub-Investigator: Peter Goldberg, M.D.         
Sponsors and Collaborators
McGill University Health Center

Responsible Party: Jacques Genest, Co-Principal Investigator, McGill University Health Center Identifier: NCT01425398     History of Changes
Other Study ID Numbers: statins_inflammation_CVsurgery
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors