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

NCT01425398 | Completed Phase 3

• 1 other identifier: statins_inflammation_CVsurgery
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Valvular Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Improved Inflammatory Markers

  Significant (p\<0.05) improvement of measured inflammatory markers

  Within 5 days post-op and at 3 months

Secondary Outcomes (4)

• Mortality

  Within 3 months

• Stroke

  Within 3 months

• Myocardial Infarction

  Within 3 months

• ICU length of stay

  3 months

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

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

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rosuvastatin DRUG

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

Also known as: Rosuvastatin 40 mg/day

Rosuvastatin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jacques Genest, MD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

CA (1)