Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Primary Purpose
Atrial Fibrillation, Cardiac Surgery
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
metoprolol, amiodarone
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Prevention
Eligibility Criteria
Inclusion Criteria:
- elective CABG and aortic valve patients in cardiac surgery,
- previous use of betablocker therapy
Exclusion Criteria:
- previous atrial fibrillation or flutter,
- thyroid disease,
- uncontrolled heart failure,
- II or III degree atrioventricular block
Sites / Locations
- Halonen jari
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
metoprolol
amiodarone
Arm Description
Outcomes
Primary Outcome Measures
Incidence of atrial fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT00784316
First Posted
October 31, 2008
Last Updated
November 23, 2011
Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland
1. Study Identification
Unique Protocol Identification Number
NCT00784316
Brief Title
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Official Title
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone in the prevention of atrial fibrillation after cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiac Surgery
Keywords
Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metoprolol
Arm Type
Active Comparator
Arm Title
amiodarone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
metoprolol, amiodarone
Intervention Description
to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery
Primary Outcome Measure Information:
Title
Incidence of atrial fibrillation
Time Frame
48 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective CABG and aortic valve patients in cardiac surgery,
previous use of betablocker therapy
Exclusion Criteria:
previous atrial fibrillation or flutter,
thyroid disease,
uncontrolled heart failure,
II or III degree atrioventricular block
Facility Information:
Facility Name
Halonen jari
City
Kuopio
ZIP/Postal Code
FIN- 70211
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21135293
Citation
Halonen J, Loponen P, Jarvinen O, Karjalainen J, Parviainen I, Halonen P, Magga J, Turpeinen A, Hippelainen M, Hartikainen J, Hakala T. Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial. Ann Intern Med. 2010 Dec 7;153(11):703-9. doi: 10.7326/0003-4819-153-11-201012070-00003.
Results Reference
derived
Learn more about this trial
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
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