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Antiarrhythmic drug
Dronedarone for Atrial Fibrillation (CHANGE-AFIB Trial)
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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
Must not have
New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks
Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
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.
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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart failure or was hospitalized for it in the last month.
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I have had or will have treatment to control heart rhythm.
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Select...
My heart's pumping ability is reduced.
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I am scheduled for heart or chest surgery.
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I have a constant irregular heartbeat.
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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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cardiovascular Hospitalization or Death
Secondary study objectives
All-cause mortality
Hospitalization for acute coronary syndrome
Hospitalization for new/worsening diagnosis of heart failure
+4 moreOther study objectives
Cardiac Arrhythmia
Days alive and outside of the hospital
Number of participants who experience AF progression
+4 moreSide effects data
From 2014 Phase 2 trial • 134 Patients • NCT0152265111%
Hypotension
7%
Oedema peripheral
7%
Fatigue
7%
Overdose
7%
Presyncope
7%
Abdominal pain
7%
Nausea
4%
International normalised ratio increased
4%
Enterococcal bacteraemia
4%
Vertigo
4%
Atrial fibrillation
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
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
Who is running the clinical trial?
Duke Clinical Research InstituteOTHER
68 Previous Clinical Trials
239,491 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
93,288 Patients Enrolled for Atrial Fibrillation
American Heart AssociationLead Sponsor
349 Previous Clinical Trials
4,954,412 Total Patients Enrolled
12 Trials studying Atrial Fibrillation
89,189 Patients Enrolled for Atrial Fibrillation
SanofiIndustry Sponsor
2,233 Previous Clinical Trials
4,075,798 Total Patients Enrolled
34 Trials studying Atrial Fibrillation
143,655 Patients Enrolled for Atrial Fibrillation
Jonathan P Piccini, MD, MHSPrincipal InvestigatorDuke Clinical Research Organization
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can sign the consent form and follow the study rules.I am 21 years old or older.I have severe heart failure or was hospitalized for it in the last month.I cannot take blood thinners orally, unless my stroke risk score is low.I have had or will have treatment to control heart rhythm.I can sign the consent form and follow the study's requirements.My heart's pumping ability is reduced.Your heart's electrical activity shows atrial fibrillation.My liver is not working well, as confirmed by my doctor.Your heart's electrical activity takes too long to reset, lasting more than 500 milliseconds.I am scheduled for heart or chest surgery.You have been diagnosed with atrial fibrillation in the last 120 days.I have been evaluated or treated for atrial fibrillation in the last 120 days.You have a heart condition called atrial fibrillation, which can be seen on an electrocardiogram.Your resting heart rate is less than 50 beats per minute.You have a heart condition where the timing between the upper and lower chambers of your heart is abnormal, and you do not have a pacemaker.I have a constant irregular heartbeat.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Dronedarone
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.