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Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE) (AFRODITE)

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: January 12, 2010
Last updated: November 9, 2011
Last verified: November 2011

The primary objective of this study is to:

Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.

The secondary objectives of this study are to compare both study arms with regard to:

  • Ventricular rate after 3 months
  • Number of registered AF episodes
  • Number of symptomatic AF episodes
  • Severity of AF and AF-like symptoms
  • Rate of premature study discontinuation
  • Number of symptomatic episodes of bradycardia
  • Incidence of low heart rate (<60 bpm)

Condition Intervention Phase
Atrial Fibrillation
Drug: Dronedarone
Drug: Beta blocker or calcium antagonist or digoxin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of the Addition of Dronedarone to, Versus Increase of, Existing Conventional Rate Control Medication on Ventricular Rate During Persistent Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Ventricular rate [ Time Frame: One week ]

Secondary Outcome Measures:
  • Ventricular rate [ Time Frame: 12 weeks ]
  • Patients with registered AF episodes [ Time Frame: Within the 12 weeks after randomization ]
  • Patients with symptomatic AF episodes [ Time Frame: Within the 12 weeks after randomization ]
  • Severity of AF and AF-like symptoms [ Time Frame: Within the 12 weeks after randomization ]
  • Premature study discontinuation [ Time Frame: Within the 12 weeks after randomization ]
    Premature study discontinuation for all reasons including those where the patients must go off study prematurely as per protocol (ie. in case of cardioversion during the 1st study week, 2nd cardioversion after the 1st study week, addition of anti-arrhythmic drug, ablation or other surgical AF related intervention)

  • Patients with symptomatic episodes of bradycardia [ Time Frame: Within the 12 weeks after randomization ]
  • Patients with low heart rate (<60 bpm) [ Time Frame: Within the 12 weeks after randomization ]

Enrollment: 183
Study Start Date: April 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Addition of dronedarone
Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)
Drug: Dronedarone
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)
Other Name: Multaq
Active Comparator: Dose Increase
Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)
Drug: Beta blocker or calcium antagonist or digoxin
Dose increase of beta blocker or calcium antagonist or digoxin


Ages Eligible for Study:   46 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Persistent AF with HR >80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - Patients using digoxin are eligible)
  • Documented AF in the past 24 hours
  • Treated with the following rate control medication:
  • beta blocker or
  • calcium antagonist or
  • beta blocker plus calcium antagonist or
  • beta blocker plus digoxin or
  • calcium antagonist plus digoxin
  • Anticoagulant treatment in line with local guidelines

Exclusion Criteria:

  • Incapacitated patients
  • Paroxysmal or permanent AF
  • Use of class I or III anti-arrhythmic drugs in the past 12 weeks
  • Scheduled cardioversion or pulmonary vein ablation
  • Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure
  • AV block grade 2 or 3
  • Known severe renal impairment (serum creatinine > 180 μmol/l)
  • Known severe hepatic impairment (AST, ALT > 3 x Upper Limit of Normal (ULN))
  • Contra-indication for dronedarone
  • Participation in a clinical drug study in the 3 months prior to inclusion
  • Women of childbearing potential, who do not use adequate contraception
  • Lactating women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01047566

Sanofi-Aventis Administrative Office
PE Gouda, Netherlands
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT01047566     History of Changes
Obsolete Identifiers: NCT01117207
Other Study ID Numbers: DRONE_L_05066
2009-018215-53 ( EudraCT Number )
Study First Received: January 12, 2010
Last Updated: November 9, 2011

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Calcium, Dietary
Calcium Channel Blockers
Adrenergic beta-Antagonists
Bone Density Conservation Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Vasodilator Agents
Potassium Channel Blockers
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors processed this record on March 28, 2017