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Antiarrhythmic agent

Dronedarone pre-cardioversion for Atrial Fibrillation

Phase 4
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Adult patients with persistent AF (current episode at the screening visit \>72 hrs and \<12 month duration), for whom cardioversion was clinically indicated and planned to reduce symptoms and antiarrhythmic treatment was clinically indicated to reduce the risk of cardiovascular hospitalization due to AF.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

Primary Objective: To determine whether daily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF. Secondary Objectives: Main Secondary : * To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation; * To assess characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient); * To compare the rates of early recurrences of AF between the two treatment strategies; Other secondary: * To assess whether there is a difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies; * To assess whether there is a difference in number of electrical cardioversions per patient between the two treatment strategies; * To assess the impact of the two strategies on number of shocks, cumulative amount of energy delivered, shock failure, and immediate success of cardioversion; * To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations and length of hospital stay between the two treatment strategies; * To assess whether there is a difference in quality of life between the two treatment strategies.

Eligible Conditions
  • Atrial Fibrillation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 2 trial • 134 Patients • NCT01522651
11%
Hypotension
7%
Oedema peripheral
7%
Fatigue
7%
Overdose
7%
Presyncope
7%
Abdominal pain
7%
Nausea
4%
Enterococcal bacteraemia
4%
Atrial fibrillation
4%
Vertigo
4%
International normalised ratio increased
4%
Chest pain
4%
Clostridium difficile colitis
4%
Cerebrovascular accident
4%
Syncope
4%
Constipation
4%
Diarrhoea
4%
Cough
4%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ranolazine 750 mg + Dronedarone 225 mg
Dronedarone 225 mg
Ranolazine 750 mg
Ranolazine 750 mg + Dronedarone 150 mg
Placebo

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dronedarone pre-cardioversionExperimental Treatment1 Intervention
Dronedarone 400 mg twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion
Group II: Placebo pre-cardioversionPlacebo Group2 Interventions
Placebo (for dronedarone) twice a day for 5-7 days prior to cardioversion, then dronedarone 400 mg twice a day for 6 months after cardioversion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronedarone
FDA approved

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,204 Previous Clinical Trials
4,036,486 Total Patients Enrolled
34 Trials studying Atrial Fibrillation
146,363 Patients Enrolled for Atrial Fibrillation
Clinical Sciences & OperationsStudy DirectorSanofi
873 Previous Clinical Trials
2,020,559 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
14,282 Patients Enrolled for Atrial Fibrillation
~18 spots leftby Nov 2025