Safety and efficacy of procainamide and amiodarone in the treatment of atrial fibrillation of recent onset

ISRCTN	ISRCTN28131679
DOI	https://doi.org/10.1186/ISRCTN28131679
Secondary identifying numbers	N/A

Submission date: 23/02/2006
Registration date: 08/03/2006
Last edited: 25/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Theodoros Xanthos
Scientific

15B Agiou Thoma street
Athens
11527
Greece

Email	theodorosxanthos@yahoo.com

Study information

Study design	Randomised double-blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To study whether procainamide and amiodarone are both effective after digoxin administration to restore sinus rhythm
Ethics approval(s)	Approved by the University of Athens on 4/5/1998, reference number 78/1998
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Procainamide, amiodarone and digoxin
Primary outcome measure	Restoration of sinus rhythm
Secondary outcome measures	1. Time of cardioversion 2. Blood pressure fluctuations
Overall study start date	05/05/1998
Completion date	20/08/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	225
Key inclusion criteria	Atrial fibrillation of recent onset (less than 24 hours)
Key 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
Date of first enrolment	05/05/1998
Date of final enrolment	20/08/2003

Locations

Countries of recruitment

Greece

Study participating centre

15B Agiou Thoma street

Athens
11527
Greece

Sponsor information

Greek National Health Service (Greece)
Government

15B Agiou Thoma street
Athens
11527
Greece

Phone	+30 (0) 2106972221
Email	lilapapadimitriou@hotmail.com

Funders

Funder type

Government

Greek National Health Service (Greece)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2007		Yes	No