Contact information
Type
Scientific
Contact name
Dr Theodoros Xanthos
ORCID ID
Contact details
15B Agiou Thoma street
Athens
11527
Greece
theodorosxanthos@yahoo.com
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
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
Overall study end date
20/08/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Atrial fibrillation of recent onset (less than 24 hours)
Participant type(s)
Patient
Age group
Adult
Sex
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
Study 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2007 | Yes | No |