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

NCT ID: NCT01047566

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-09-30

Brief Summary

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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)

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Addition of dronedarone

Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)

Group Type EXPERIMENTAL

Dronedarone

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)

Dose Increase

Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)

Group Type ACTIVE_COMPARATOR

Beta blocker or calcium antagonist or digoxin

Intervention Type DRUG

Dose increase of beta blocker or calcium antagonist or digoxin

Interventions

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Dronedarone

Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)

Intervention Type DRUG

Beta blocker or calcium antagonist or digoxin

Dose increase of beta blocker or calcium antagonist or digoxin

Intervention Type DRUG

Other Intervention Names

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Multaq

Eligibility Criteria

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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.
Minimum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

PE Gouda, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2009-018215-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRONE_L_05066

Identifier Type: -

Identifier Source: org_study_id

NCT01117207

Identifier Type: -

Identifier Source: nct_alias