Cardiothoracic Surgery, Post-operative Atrial Fibrillation
Conditions
Keywords
post-operative atrial fibrillation, POAF, A-Fib
Brief summary
This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.
Detailed description
This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.
Interventions
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of atrial fibrillation by hospital discharge | Hospital discharge, an expected 5-7 days | Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings. |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay | Hospital discharge, an expected 5-7 days |
| Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days | 30 days |
Countries
United States
Contacts
Primary ContactCaroline Nubel
Outcome results
None listed