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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN28131679 |
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Date of registration:
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08/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and efficacy of procainamide and amiodarone in the treatment of atrial fibrillation of recent onset
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Scientific title:
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Date of first enrolment:
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05/05/1998 |
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Target sample size:
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225 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN28131679 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Theodoros
Xanthos |
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Address:
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15B Agiou Thoma street
11527
Athens
Greece |
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Telephone:
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Email:
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theodorosxanthos@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Atrial fibrillation of recent onset (less than 24 hours)
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial fibrillation
Circulatory System
Atrial fibrillation
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Intervention(s)
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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.
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Primary Outcome(s)
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Restoration of sinus rhythm
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Secondary Outcome(s)
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1. Time of cardioversion
2. Blood pressure fluctuations
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Source(s) of Monetary Support
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Greek National Health Service (Greece)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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