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

NCT ID: NCT01425398

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Conditions

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Valvular Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rosuvastatin

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

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Rosuvastatin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Rosuvastatin 40 mg/day

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Jacques Genest

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacques Genest, MD

Role: PRINCIPAL_INVESTIGATOR

RI-MUHC

Locations

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Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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statins_inflammation_CVsurgery

Identifier Type: -

Identifier Source: org_study_id