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Antiarrhythmic drug
Dronedarone for Atrial Fibrillation(CHANGE-AFIB Trial)
Phase 4
Recruiting
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
First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upat baseline and 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
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.
CHANGE-AFIB Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must be 21 years old or older.
Select...
You have been diagnosed with atrial fibrillation in the last 120 days.
Select...
Your heart's electrical activity shows atrial fibrillation.
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
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 moreOther outcome measures
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%
Presyncope
7%
Abdominal pain
7%
Nausea
7%
Overdose
4%
Vertigo
4%
Enterococcal bacteraemia
4%
Chest pain
4%
Clostridium difficile colitis
4%
International normalised ratio increased
4%
Cerebrovascular accident
4%
Syncope
4%
Atrial fibrillation
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
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
Find a Location
Who is running the clinical trial?
American Heart AssociationLead Sponsor
307 Previous Clinical Trials
4,912,617 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
72,139 Patients Enrolled for Atrial Fibrillation
Duke Clinical Research InstituteOTHER
60 Previous Clinical Trials
237,387 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
93,288 Patients Enrolled for Atrial Fibrillation
SanofiIndustry Sponsor
2,132 Previous Clinical Trials
3,105,193 Total Patients Enrolled
34 Trials studying Atrial Fibrillation
143,655 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be at least 21 years old.You have a documented irregular heartbeat called atrial fibrillation on an electrocardiogram.You have been diagnosed with atrial fibrillation within the last 120 days.You have been to the hospital 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.Your heart's electrical activity takes too long to reset, lasting more than 500 milliseconds.The doctor thinks your liver is very sick.You have had or are planning to have treatment for heart rhythm control with a procedure called catheter ablation or long-term use of certain medications for heart rhythm.You are scheduled to have surgery on your heart or chest.You have severe heart failure or were hospitalized for heart failure in the last 4 weeks.Your heart's pumping ability is significantly reduced (LVEF ≤40%).You are expected to live for at least 1 more year.You have a constant irregular heartbeat (atrial fibrillation).You were diagnosed with atrial fibrillation in the last 120 days.You have been diagnosed with atrial fibrillation in the last 120 days.Your heart's electrical activity shows atrial fibrillation.You cannot take blood thinning pills, unless your CHA2DS2-VASc score is less than 3 for women or 2 for men.You must be 21 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Dronedarone
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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. 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
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Penn State Health Holy Spirit Medical Center
Kettering Medical Center
Memorial Hermann - Texas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I can't afford Eliquis.
PatientReceived no prior treatments
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