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

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Completed
CT.gov ID
NCT01425398
Collaborator
(none)
170
Enrollment
1
Location
2
Arms
25
Duration (Months)
6.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual 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 :
Nov 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosuvastatin

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

Drug: Rosuvastatin
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 Comparator: Placebo

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Improved Inflammatory Markers [Within 5 days post-op and at 3 months]

      Significant (p<0.05) improvement of measured inflammatory markers

    Secondary Outcome Measures

    1. Mortality [Within 3 months]

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

    2. Stroke [Within 3 months]

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

    3. Myocardial Infarction [Within 3 months]

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

    4. ICU length of stay [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 (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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Victoria Hospital Montreal Quebec Canada H3A 1A1

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jacques Genest, MD, RI-MUHC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jacques Genest, Co-Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
    ClinicalTrials.gov Identifier:
    NCT01425398
    Other Study ID Numbers:
    • statins_inflammation_CVsurgery
    First Posted:
    Aug 30, 2011
    Last Update Posted:
    Oct 21, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Inflammation
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Oct 21, 2021