Atrial fibrillation
Conditions
Interventions
Trade Name: Cordarone X 100
Cordarone X 200
Product Name: Amiodarone/Cordarone X 100/Cordarone X 200
Pharmaceutical Form: Tablet
INN or
Sponsors
Oxford Radcliffe Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: atrial fibrillation 30 days to year duration Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) paroxysmal atrial fibrillation 2) failure to convert to sinus rhythm after 28 days of Amiodarone treatment and attempted electrical cardioversion 3) previous treatment with Amiodarone 4) myocardial infarction within last 6 months 5) cardiac surgery during past 30 days 6) atrial fibrillation associated with acute reversible condition 7) significant sinoatrial disease (sinus bradycardia 2 seconds while awake) 8)2nd or 3rd degree atrioventricular block without a permanenet pacemaker (contradiction to Amiodarone) 9) History of Torsades de pointes (contradiction to Amiodarone) 10) QTc > 480ms (contradiction to Amiodarone) 11) Uncorrected thyroid dysfunction (contradiction to Amiodarone) 12) Elevated hepatic enzymes (contradiction to Amiodarone) 13) History of interstitial pulmonary disease (contradiction to Amiodarone) 14) Predicted life expectance < 1 year due to other major medical problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: comparing 2 doses of one drug for the maintenance of sinus rhythm after DC cardioversion;Secondary Objective: comparing 2 doses of one drug with respect to side effects;Primary end point(s): maintenance of sinus rhythma | — |
Countries
United Kingdom
Outcome results
None listed