Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01140581
• Date of registration: 08/06/2010
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation ARTEMIS Load
• Scientific title: A Randomized, International, Multi-center, Open-label Study to Document Optimal Timing of Initiation of Dronedarone Treatment After Conversion With Loading Dose of Amiodarone in Patients With Persistent Atrial Fibrillation Requiring Conversion of AF.
• Date of first enrolment: September 2010
• Target sample size: 402
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01140581
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Australia, Austria, Estonia, Finland, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Spain, Switzerland, Taiwan, United Kingdom

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: DRONEDARONE

Primary Outcome(s)

AF recurrences [Time Frame: one month after randomization]

Secondary Outcome(s)

AF recurrences [Time Frame: two months after randomization]

Symptomatic bradycardia [Time Frame: two months after randomization]

Dronedarone and amiodarone concentrations in plasma [Time Frame: 3 hours, 1 week, 2 weeks and 4 weeks after 1st Dronedarone intake]

Tachycardia [Time Frame: two months after randomization]

Secondary ID(s)

DRONE_C_03668

2009-016818-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors