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

October 13, 2021 updated by: Jacques Genest, McGill University Health Centre/Research Institute of the McGill University Health Centre

A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Inflammatory Markers
Time Frame: Within 5 days post-op and at 3 months
Significant (p<0.05) improvement of measured inflammatory markers
Within 5 days post-op and at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Within 3 months
Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo
Within 3 months
Stroke
Time Frame: Within 3 months
Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo
Within 3 months
Myocardial Infarction
Time Frame: Within 3 months
Significant (p<0.05) reduction of MI events in rosuvastatin arm versus
Within 3 months
ICU length of stay
Time Frame: 3 months
Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • statins_inflammation_CVsurgery

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Valvular Cardiac Surgery

Clinical Trials on Rosuvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe