Status:
COMPLETED
Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
Lead Sponsor:
Sanofi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Objective: \- Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: * Eva...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Screening:
- Persistent AF for more than 72 hours (documented by an ECG taken within the last 72 hours) for whom cardioversion, anti-arrhythmic treatment and anticoagulation treatment are indicated in the opinion of the Investigator
- Naive of amiodarone treatment in the last three months
- QTc Bazett \< 500 ms on 12-lead ECG,
- At least one cardiovascular risk factor (i.e. age \> 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter \>= 50 mm
- Randomization:
- Outpatient and Inpatients (except patients hospitalized during screening period for SAE)
- Sinus rhythm
- Effective oral anticoagulation verified by International Normalized Ratio/INR (target \> 2)
- QTc Bazett \< 500 ms and PR \< 280 ms on 12-lead ECG
- Completed treatment period with amiodarone (28 days ± 2 days)
- Exclusion criteria:
- Screening:
- Contraindication to oral anticoagulation
- Acute condition known to cause AF
- Permanent AF
- Paroxysmal AF
- Bradycardia \< 50 bpm on the 12-lead ECG
- Clinically overt congestive heart failure:
- with New York Heart Association (NYHA) classes III and IV heart failure
- with LVEF \< 35%
- or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic
- or unstable hemodynamic conditions
- Severe hepatic impairment
- Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) if taken less than one week
- Previous history of amiodarone intolerance or toxicity
- Any contraindication as per dronedarone and amiodarone labelling
- Wolff-Parkinson-White Syndrome
- Previous ablation for atrial fibrillation or any planned ablation in the next 2 months
- Contraindicated concomitant treatment:
- Potent cytochrome P450 (CYP3A4) inhibitors
- Use of drugs or herbal products that prolong the QT interval and known to increase the risk of Torsades de Pointes
- Class I or III anti-arrhythmic drugs (including sotalol)
- Randomization:
- Bradycardia \< 50 bpm on the 12-lead ECG
- Clinically overt congestive heart failure:
- with New York Heart Association (NYHA) classes III and IV heart failure
- with LVEF \< 35%
- or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic
- or unstable hemodynamic conditions
- Severe hepatic impairment
- Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) if taken less than one week
- Patient in whom the following contraindicated concomitant treatment is mandatory:
- Potent cytochrome P450 (CYP3A4) inhibitors
- Use of drugs or herbal products that prolong the QT interval and known to increase the risk of Torsades de Pointes
- Class I or III anti-arrhythmic drugs (including sotalol)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT01140581
Start Date
September 1 2010
End Date
December 1 2011
Last Update
January 23 2012
Active Locations (111)
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1
Investigational Site Number 009
Adelaide, Australia, 5000
2
Investigational Site Number 013
Ballarat, Australia, 3350
3
Investigational Site Number 002
Garran, Australia, 2605
4
Investigational Site Number 007
Herston, Australia, 4006