Intravenous and oral administration of amiodarone for the management of recent onset atrial fibrillation (AF): a randomized, digoxin and disopyramide controlled trial
| ISRCTN | ISRCTN87656977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87656977 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/02/2006
- Registration date
- 07/03/2006
- Last edited
- 18/02/2008
- 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
| Phone | +30 (0)2107462550 |
|---|---|
| theodorosxanthos@yahoo.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To confirm if oral amiodarone is as effective as intravenous amiodarone in restoring sinus rhythm in patients with recent AF. |
| Ethics approval(s) | Provided by the Ethics Committee of the Medical School of the University of Athens on 12/03/1999. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | amiodarone |
| Primary outcome measure | Restoration of sinus rhythm |
| Secondary outcome measures | Blood pressure monitoring |
| Overall study start date | 24/04/1999 |
| Completion date | 30/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 223 |
| Key inclusion criteria | Patients with recent onset atrial fibrillation |
| 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 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 |
| Date of first enrolment | 24/04/1999 |
| Date of final enrolment | 30/12/2004 |
Locations
Countries of recruitment
- Greece
Study participating centre
15B Agiou Thoma street
Athens
11527
Greece
11527
Greece
Sponsor information
Greek National Health Service (Greece)
Government
Government
15B Agiou Thoma street
Athens
11527
Greece
| Phone | +30 (0) 2107462501 |
|---|---|
| dperrea@med.uoa.gr |
Funders
Funder type
Government
Greek National Health Service
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 | 18/10/2007 | Yes | No |
