Dronedarone for Atrial Fibrillation

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Atrial Fibrillation
Dronedarone - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing whether or not dronedarone, an antiarrhythmic drug, is effective in reducing cardiovascular hospitalization or death in patients with first-detected AF.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: At baseline and 12 months

Month 12
Patient-Reported Quality of Life--AFEQT
Patient-Reported Quality of Life--MAFSI
Month 12
All-cause mortality
Cardiac Arrhythmia
Cardiovascular Hospitalization or Death
Days alive and outside of the hospital
Hospitalization for acute coronary syndrome
Hospitalization for new/worsening diagnosis of heart failure
Ischemic stroke or systemic embolism
Number of participants who experience AF progression
Number of participants who have ablation of AF (catheter, surgical or hybrid) performed
Number of participants who undergo cardioversion (pharmacologic or electrical)
Time to first unplanned cardiovascular hospitalization
Unplanned cardiovascular hospitalizations--secondary analysis using Anderson-Gill extension
Win Ratio

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ranolazine 750 mg + Dronedarone 225 mg
11%Hypotension
7%Abdominal pain
7%Nausea
7%Fatigue
7%Overdose
7%Oedema peripheral
7%Presyncope
4%Chest pain
4%Cerebrovascular accident
4%Diarrhoea
4%Constipation
4%Atrial fibrillation
4%Vertigo
4%Enterococcal bacteraemia
4%Clostridium difficile colitis
4%International normalised ratio increased
4%Syncope
4%Cough
4%Dyspnoea
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01522651) in the Ranolazine 750 mg + Dronedarone 225 mg ARM group. Side effects include: Hypotension with 11%, Abdominal pain with 7%, Nausea with 7%, Fatigue with 7%, Overdose with 7%.

Trial Design

2 Treatment Groups

Usual care
1 of 2
Dronedarone
1 of 2

Active Control

Experimental Treatment

3000 Total Participants · 2 Treatment Groups

Primary Treatment: Dronedarone · No Placebo Group · Phase 4

Dronedarone
Drug
Experimental Group · 1 Intervention: Dronedarone · Intervention Types: Drug
Usual careNoIntervention Group · 1 Intervention: Usual care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronedarone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline and 12 months

Who is running the clinical trial?

American Heart AssociationLead Sponsor
281 Previous Clinical Trials
5,820,770 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
72,108 Patients Enrolled for Atrial Fibrillation
SanofiIndustry Sponsor
2,030 Previous Clinical Trials
2,905,669 Total Patients Enrolled
34 Trials studying Atrial Fibrillation
143,963 Patients Enrolled for Atrial Fibrillation
Duke Clinical Research InstituteOTHER
57 Previous Clinical Trials
228,317 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
93,288 Patients Enrolled for Atrial Fibrillation
Jonathan P Piccini, MD, MHSPrincipal InvestigatorDuke Clinical Research Organization

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References