Contact information
Type
Scientific
Primary contact
Dr Theodoros Xanthos
ORCID ID
Contact details
15B Agiou Thoma street
Athens
11527
Greece
+30 (0)2107462550
theodorosxanthos@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To confirm if oral amiodarone is as effective as intravenous amiodarone in restoring sinus rhythm in patients with recent AF.
Ethics approval
Provided by the Ethics Committee of the Medical School of the University of Athens on 12/03/1999.
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Atrial fibrillation
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
amiodarone
Primary outcome measure
Restoration of sinus rhythm
Secondary outcome measures
Blood pressure monitoring
Overall trial start date
24/04/1999
Overall trial end date
30/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with recent onset atrial fibrillation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
223
Participant exclusion criteria
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
Recruitment start date
24/04/1999
Recruitment end date
30/12/2004
Locations
Countries of recruitment
Greece
Trial participating centre
15B Agiou Thoma street
Athens
11527
Greece
Sponsor information
Organisation
Greek National Health Service (Greece)
Sponsor details
15B Agiou Thoma street
Athens
11527
Greece
+30 (0) 2107462501
dperrea@med.uoa.gr
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Greek National Health Service
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17434635
Publication citations
-
Results
Xanthos T, Bassiakou E, Vlachos IS, Bassiakos S, Michalakis K, Moutzouris DA, Papadimitriou L, Intravenous and oral administration of amiodarone for the treatment of recent onset atrial fibrillation after digoxin administration., Int. J. Cardiol., 2007, 121, 3, 291-295, doi: 10.1016/j.ijcard.2007.02.024.