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Antiarrhythmic drug

Dronedarone for Atrial Fibrillation (CHANGE-AFIB Trial)

Phase 4

Waitlist Available

Led By Jonathan P Piccini, MD, MHS

Research Sponsored by American Heart Association

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=21 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and 12 months

Awards & highlights

CHANGE-AFIB Trial 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.

Who is the study for?

This trial is for adults over 21 with newly diagnosed atrial fibrillation (AF) within the last 120 days, who have been hospitalized for AF evaluation or treatment. Participants must be expected to live at least another year and give informed consent. Excluded are those with severe heart rate or rhythm issues, significant liver impairment, pregnant or breastfeeding women, patients on certain heart treatments, and those ineligible for blood-thinning medication.Check my eligibility

What is being tested?

The study tests if early use of Dronedarone (400 mg twice daily), in addition to usual care like beta-blockers and stroke prevention therapy based on CHA2DS2-VASc score, can prevent cardiovascular hospitalization or death compared to usual care alone in patients with first-detected AF. The trial will follow participants for a year with two check-ups.See study design

What are the potential side effects?

Dronedarone may cause side effects such as nausea, diarrhea, rash and an increased risk of liver damage. It might also affect heart rhythms leading to slow heartbeat or other rhythm-related complications.

CHANGE-AFIB Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 21 years old or older.

CHANGE-AFIB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiovascular Hospitalization or Death

Secondary outcome measures

All-cause mortality

Hospitalization for acute coronary syndrome

Hospitalization for new/worsening diagnosis of heart failure

+4 more

Other outcome measures

Cardiac Arrhythmia

Days alive and outside of the hospital

Number of participants who experience AF progression

+4 more

Side effects data

From 2014 Phase 2 trial • 134 Patients • NCT01522651

11%

Hypotension

Fatigue

Overdose

Oedema peripheral

Presyncope

Abdominal pain

Nausea

Vertigo

Atrial fibrillation

International normalised ratio increased

Enterococcal bacteraemia

Chest pain

Clostridium difficile colitis

Cerebrovascular accident

Syncope

Constipation

Diarrhoea

Cough

Dyspnoea

100%

80%

60%

40%

20%

Study treatment Arm

Ranolazine 750 mg + Dronedarone 225 mg

Dronedarone 225 mg

Ranolazine 750 mg

Ranolazine 750 mg + Dronedarone 150 mg

Placebo

CHANGE-AFIB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DronedaroneExperimental Treatment1 Intervention

In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the United States Prescribing Information (USPI) when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

Group II: Usual careActive Control1 Intervention

In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dronedarone

2010

Completed Phase 4

~570

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke Clinical Research InstituteOTHER

63 Previous Clinical Trials

238,532 Total Patients Enrolled

5 Trials studying Atrial Fibrillation

93,288 Patients Enrolled for Atrial Fibrillation

American Heart AssociationLead Sponsor

324 Previous Clinical Trials

4,930,778 Total Patients Enrolled

11 Trials studying Atrial Fibrillation

89,337 Patients Enrolled for Atrial Fibrillation

SanofiIndustry Sponsor

2,163 Previous Clinical Trials

3,509,480 Total Patients Enrolled

34 Trials studying Atrial Fibrillation

143,655 Patients Enrolled for Atrial Fibrillation

Media Library

Dronedarone (Antiarrhythmic drug) Clinical Trial Eligibility Overview. Trial Name: NCT05130268 — Phase 4

Atrial Fibrillation Research Study Groups: Usual care, Dronedarone

Atrial Fibrillation Clinical Trial 2023: Dronedarone Highlights & Side Effects. Trial Name: NCT05130268 — Phase 4

Dronedarone (Antiarrhythmic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130268 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are currently managing this research project?

"Presently, this medical study is available in 26 centres located throughout the USA, including Cleveland, Madison and Lansing. To reduce travel needs during enrollment it can be beneficial to choose a trial site that is geographically proximate."

Answered by AI

Has Dronedarone achieved governmental affirmation for medicinal use?

"With its Phase 4 status, Dronedarone has been approved and thus receives a score of 3 in terms of safety."

Answered by AI

Have there been prior investigations utilizing Dronedarone?

"Currently, there are 4 active clinical trials concerning the potential of Dronedarone. All of these studies are at Phase 2 or earlier. The majority of research is based in New Orleans, Louisiana; however, 32 total sites across the nation have been identified for this treatment's investigation."

Answered by AI

How many participants are enrolled in this research project?

"Affirmative. According to the clinicaltrials.gov entry for this project, it is actively enrolling 3000 volunteers between a total of 26 sites; This research was first posted on October 29th 2021 and its details were last updated November 22nd 2022."

Answered by AI

Is enrollment currently open for this research endeavor?

"Affirmative. Data published on clinicaltrials.gov verifies that this investigation, initially posted on October 29th 2021, is currently recruiting participants. Approximately 3000 patients are needed from 26 medical centres."

Answered by AI