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

McGill University logo

McGill University

Status and phase

Completed
Phase 3

Conditions

Valvular Cardiac Surgery

Treatments

Drug: Rosuvastatin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01425398
statins_inflammation_CVsurgery

Details and patient eligibility

About

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

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

170 participants in 2 patient groups, including a placebo group

Rosuvastatin
Experimental group
Description:
Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5.
Treatment:
Drug: Rosuvastatin
Placebo
Placebo Comparator group
Description:
Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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