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

This study is not yet open for participant recruitment.
Verified August 2011 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Jacques Genest, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01425398
First received: August 26, 2011
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Valvular Cardiac Surgery
 Drug: Rosuvastatin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Improved Inflammatory Markers [ Time Frame: Within 5 days post-op and at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Within 3 months ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: Within 3 months ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: Within 3 months ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425398

Locations
Canada, Quebec
Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Jennifer Chung, M.D.     438-886-3901     jennifer.chung2@mail.mcgill.ca    
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
  More Information

No publications provided

Responsible Party: Jacques Genest, Co-Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01425398     History of Changes
Other Study ID Numbers: statins_inflammation_CVsurgery
Study First Received: August 26, 2011
Last Updated: August 29, 2011
Health Authority: Canada: MUHC Department of Surgery

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013