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 |
| Protocol serial number | N/A |
| Sponsor | Greek National Health Service (Greece) |
| Funder | Greek National Health Service (Greece) |
- 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
Scientific
15B Agiou Thoma street
Athens
11527
Greece
| theodorosxanthos@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Procainamide, amiodarone and digoxin |
| Primary outcome measure(s) |
Restoration of sinus rhythm |
| Key secondary outcome measure(s) |
1. Time of cardioversion |
| Completion date | 20/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
11527
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
