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Main
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Note: This record shows only 22 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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27 June 2016 |
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Main ID: |
NCT02029534 |
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Date of registration:
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16/08/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
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Scientific title:
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Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02029534 |
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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: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Aiman Smer, MBBCh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Creighton University |
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Name:
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Caroline Nubel |
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Address:
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Telephone:
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402-280-4032 |
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Email:
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carolinenubel@creighton.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 19 or older
- Undergoing elective cardiothoracic surgery
Exclusion Criteria:
- Emergency cardiothoracic surgery
- History of permanent atrial fibrillation
- Acute coronary syndrome within 7 days
- Antiarrhythmic drug use in the past 3 months
- Receiving maximal tolerated dose of statin therapy
- Receiving fibrate therapy
- History of statin intolerance
- Significant liver impairment (aspartate aminotransferase/alanine
aminotransferase(AST/ALT)>2x ULN)
- Serum Creatinine > 3 mg/dl
- Pregnancy or breastfeeding
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Post-operative Atrial Fibrillation
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Cardiothoracic Surgery
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Intervention(s)
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Drug: Atorvastatin 20 mg
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Drug: Atorvastatin 80 mg
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Primary Outcome(s)
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Occurrence of atrial fibrillation by hospital discharge
[Time Frame: Hospital discharge, an expected 5-7 days]
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Secondary Outcome(s)
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Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days
[Time Frame: 30 days]
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Length of hospital stay
[Time Frame: Hospital discharge, an expected 5-7 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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