Condition category
Circulatory System
Date applied
23/02/2006
Date assigned
08/03/2006
Last edited
25/09/2009
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
theodorosxanthos@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To study whether procainamide and amiodarone are both effective after digoxin administration to restore sinus rhythm

Ethics approval

Approved by the University
of Athens on 4/5/1998, reference number 78/1998

Study design

Randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Atrial fibrillation

Intervention

After administration of digitalis (digoxin), and in case of failure to restore Sinus Rhythm (SR), the patients were randomized into two groups. Randomization was performed with the use of sealed envelopes, thus guaranteeing an almost equal number of patients.
Group A (113 patients) received amiodarone intravenously 300 mg in 30 minutes and in case of failure to restore SR, amiodarone was continued for a further 24 hours as an intravenous infusion (maintenance) of 20 mg/kg.
Group B (110 patients) were administered a bolus dose of 1 g intravenous procainamide, and in the case of failure to restore sinus rhythm in 30 minutes, 2 mg/min (maintenance) for the next 24 hours. The other two participants decided to be treated privately, therefore both received digitalis and the study medication, but did not stay in the NHS long enough to be included in the study.

Intervention type

Drug

Phase

Not Specified

Drug names

Procainamide, amiodarone and digoxin

Primary outcome measures

Restoration of sinus rhythm

Secondary outcome measures

1. Time of cardioversion
2. Blood pressure fluctuations

Overall trial start date

05/05/1998

Overall trial end date

20/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Atrial fibrillation of recent onset (less than 24 hours)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

225

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 anti-arrhythmic drug
6. Documented permanent AF, atrial flutter and a corrected heart rate (QTc) interval >440 msec

Recruitment start date

05/05/1998

Recruitment end date

20/08/2003

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) 2106972221
lilapapadimitriou@hotmail.com

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Greek National Health Service (Greece)

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 in http://www.ncbi.nlm.nih.gov/pubmed/17653020

Publication citations

  1. Results

    Xanthos T, Prapa V, Papadimitriou D, Papadimitriou L, Comparative study of intravenous amiodarone and procainamide in the treatment of atrial fibrillation of recent onset., Minerva Cardioangiol, 2007, 55, 4, 433-441.

Additional files

Editorial Notes