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ISRCTN
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ISRCTN87656977
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ClinicalTrials.gov identifier
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Public title
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Intravenous and oral administration of amiodarone for the management of recent onset atrial fibrillation (AF): a randomized, digoxin and disopyramide controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To confirm if oral amiodarone is as effective as intravenous amiodarone in restoring sinus rhythm in patients with recent AF.
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Lay summary
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Ethics approval
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Provided by the Ethics Committee of the Medical School of the University of Athens on 12/03/1999.
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Study design
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Randomized controlled trial
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Atrial fibrillation
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Participants - inclusion criteria
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Patients with recent onset atrial fibrillation
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Participants - exclusion criteria
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1. Age <18 years
2. Baseline systolic blood pressure <100 mmHg
3. Known thyroid disease
4. Serum potassium <3.5 mmol/l
5. Pre-treatment with any antiarrhythmic drug
6. Documented permanent AF
7. Atrial flutter and corrected heart rate (QTc) interval >440 msec
8. The duration of tachyarrhythmia estimated by medical history
9. The current guidelines regarding prevention of thromboembolism are also followed
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Anticipated start date
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24/04/1999
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Anticipated end date
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30/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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223
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Interventions
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All patients, a total number of 338 received digoxin and disopyramide and if this restored sinus rhythm within two hours, they were excluded from the study.
Patients were randomized into two groups. One group received intravenous amiodarone
and the other group received oral amiodarone.
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Primary outcome measure(s)
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Restoration of sinus rhythm
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Secondary outcome measure(s)
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Blood pressure monitoring
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Sources of funding
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Greek National Health Service
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Trial website
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Publications
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2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17434635
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Contact name
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Dr
Theodoros
Xanthos
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Address
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15B Agiou Thoma street
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Tel
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+30 (0)2107462550
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Email
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theodorosxanthos@yahoo.com
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Sponsor
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Greek National Health Service (Greece)
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Address
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15B Agiou Thoma street
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Tel
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+30 (0) 2107462501
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Email
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dperrea@med.uoa.gr
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Date applied
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05/02/2006
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Last edited
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18/02/2008
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Date ISRCTN assigned
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07/03/2006
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