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

Primary Purpose

Valvular Cardiac Surgery

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Valvular Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rosuvastatin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improved Inflammatory Markers
Significant (p<0.05) improvement of measured inflammatory markers

Secondary Outcome Measures

Mortality
Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo
Stroke
Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo
Myocardial Infarction
Significant (p<0.05) reduction of MI events in rosuvastatin arm versus
ICU length of stay
Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo

Full Information

First Posted
August 26, 2011
Last Updated
October 13, 2021
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01425398
Brief Title
A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
Official Title
A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Cardiac Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Rosuvastatin 40 mg/day
Intervention Description
Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5.
Primary Outcome Measure Information:
Title
Improved Inflammatory Markers
Description
Significant (p<0.05) improvement of measured inflammatory markers
Time Frame
Within 5 days post-op and at 3 months
Secondary Outcome Measure Information:
Title
Mortality
Description
Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo
Time Frame
Within 3 months
Title
Stroke
Description
Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo
Time Frame
Within 3 months
Title
Myocardial Infarction
Description
Significant (p<0.05) reduction of MI events in rosuvastatin arm versus
Time Frame
Within 3 months
Title
ICU length of stay
Description
Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Genest, MD
Organizational Affiliation
RI-MUHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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