Condition category
Circulatory System
Date applied
05/02/2006
Date assigned
07/03/2006
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17434635

Publication citations

  1. 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.

Additional files

Editorial Notes