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Dronedarone for Atrial Fibrillation(CHANGE-AFIB Trial)
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 CriteriaYou will be eligible if you check “Yes” for the criteria below
CHANGE-AFIB Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2014 Phase 2 trial • 134 Patients • NCT01522651
Awards & Highlights
CHANGE-AFIB Trial Design
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Who is running the clinical trial?
- 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.
- Group 1: Usual care
- Group 2: Dronedarone
- 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.
- 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
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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