Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 16, 2016
June 1, 2016
3.8 years
August 16, 2013
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of atrial fibrillation by hospital discharge
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.
Hospital discharge, an expected 5-7 days
Secondary Outcomes (2)
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
Study Arms (2)
Atorvastatin 20 mg
ACTIVE COMPARATORatorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery
Atorvastatin 80 mg
EXPERIMENTALatorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery
Interventions
Eligibility Criteria
You may qualify if:
- Age 19 or older
- Undergoing elective cardiothoracic surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Creighton University
Omaha, Nebraska, 68131, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aiman Smer, MBBCh
Creighton University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2013
First Posted
January 8, 2014
Study Start
August 1, 2013
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 16, 2016
Record last verified: 2016-06