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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00967434 |
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Date of registration:
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26/08/2009 |
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Primary sponsor: |
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Public title:
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Statin Drugs to Prevent Complications During Surgery
STAR-VaS |
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Scientific title:
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Short Term Atorvastatin Regime for Vasculopathic Surgical (STAR-VaS) Patients Study |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00967434 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Canada
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Contacts
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Name:
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David T Neilipovitz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Greg L Bryson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- elective high-risk surgery defined by use of the POISE criteria
- over 45 years of age
Exclusion Criteria:
- lack of informed consent
- contraindication to statin (i.e. liver insufficiency or cirrhosis, active muscular
disorder or myopathy, or previous adverse reaction to statin)
- pregnant
- enrolled in another conflicting study
- previously enrolled in STAR VaS
- presently using a statin drug
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inflammation
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Myocardial Infarction
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Myocardial Ischemia
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Intervention(s)
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Drug: Atorvastatin
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Drug: Placebo
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Primary Outcome(s)
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C-reactive protein levels at 48 hours postoperatively
[Time Frame: 48 hours]
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Secondary Outcome(s)
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liver enzyme levels
[Time Frame: up to 7 postoperative days]
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myopathy as assessed by CK levels
[Time Frame: up to 7 postoperative days]
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perioperative myocardial injury as measured by troponin levels
[Time Frame: up to 7 postoperative days]
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perioperative myocardial ischemia as detected by Holter monitoring
[Time Frame: 48 hours]
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Secondary ID(s)
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2006832-01H
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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