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MAT-US-2201785(v3.0)-PRO1
Approved Distribution Exp: 12-31-2023
Early Dronedarone Versus Usual Care to Improve Outcomes
in Persons With Newly Diagnosed Atrial Fibrillation: The CHANGE AFib Trial
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Rationale and aim of the CHANGE AFib trial
AFib is the most common sustained
heart arrhythmia and it accounts
for 1/3 of hospitalizations1,2
AFib contributes to
~158,000 deaths per year1
12.1 million
people in the US that may be affected
with AFib by 2030, more than double
than in 20103
1 in 5 patients
who present with stroke have
first-detected, or newly diagnosed, AFib4
HOWEVER…
Until recently, there have been NO randomized
clinical trials of therapy for first-detected AFib5
Evidence on the best early treatment
plan for first-detected AFib is missing6
Dronedarone is an antiarrhythmic drug and has been approved by the US FDA in certain
patients with AFib since 20097
Aim of the Trial
The CHANGE AFib trial aims to determine if early treatment with dronedarone improves CV and long
term outcomes in patients presenting to the hospital with first-detected AFib5,6
Design of the CHANGE AFib trial
CHANGE AFib is an open-label pragmatic clinical trial open to U.S. hospitals participating
in the American Heart Association’s GWTG® - AFib (GWTG-AFib) Program5,6,8
Key eligibility criteria5,8,9
Aged ≥21 years
ECG documentation
of first-detected AFib
(diagnosed in the
previous 120 days)
Estimated life
expectancy of
≥1 year
No prior rhythm
control treatment
(antiarrhythmic
drugs or ablation)
No prior
hospitalization
for AFib
Trial design5,8,9
Randomization (1:1)
N = 3000
Dronedarone 400 mg BID + usual care*
Control (usual care*)
Key efficacy and safety endpoints5,8,9
Primary endpoint:
  • Time to 1st CV hospitalizaton
    or death from any cause
    within 12 months from
    randomization
Secondary efficacy endpoints:
  • WIN Ratio (according to the
    following hierarchy)
    • All-cause mortality
    • Ischemic stroke or
      systemic embolism
    • Hospitalization for new
      diagnosis of HF
    • Hospitalization for acute
      coronary syndrome
  • CV hospitalization
  • All-cause mortality
Tertiary endpoints:
  • Ischemic stroke/
    systemic embolism
  • Arrhythmia-related
    hospitalization
  • HF hospitalization
  • AFib progression
  • Cardioversion
  • Catheter ablation of AFib
  • Days alive and out of hospital
Patient reported outcomes:
  • AFEQT
  • MAFSI
Safety endpoints
  • Key adverse/safety
    events of interest
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Prescribing Information
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ClinicalTrials.gov

The use of dronedarone in this study is
investigational, the safety and efficacy of the use
under investigation has not been established, and
it has not been evaluated by any regulatory agency.

Principal investigator: Jonathan Piccini M.D.
M.H.S., Duke Clinical Research Organization,
American Heart Association volunteer

ClinicalTrials.gov Identifier: NCT05130268

MAT-US-2201785(v3.0)-PRO1
Approved Distribution Exp: 12-31-2023

CHANGE AFib is a collaboration
between the American Heart
Association and the Duke Clinical
Research Institute, with support
from Sanofi US Services Inc.
*Includes 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.
Abbreviations: AFEQT: Atrial Fibrillation Effect on QualiTy-of-life questionnaire; AFib: atrial fibrillation; BID: twice a day; CV: cardiovascular; ECG: electrocardiogram;
FDA: Food and Drug Administration; GWTG®: Get With The Guidelines®; HF: heart failure; MAFSI: Mayo AFib-Specifc Symptom Inventory; R: randomization.
References: 1. Centers for Disease Control. Patient Education Handout: Atrial fibrillation. Available at: www.cdc.gov/heartdisease/atrial_fibrillation.htm. Accessed
February 4, 2022. 2. American Heart Association. Available at: https://www.heart.org/en/professional/quality-improvement/get-with-the-guidelines/get-with-the-guide
lines-afib/joining-forces-for-atrial-fibrillation-patients. Accessed February 10, 2022. 3. Colilla S, et al. Am J Cardiol. 2013;112:1142–1147. 4. Jaakkola J, et al. PLoS One.
2016;11(12):e0168010. 5. Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation (CHANGE AFIB). Available at:
https://clinicaltrials.gov/ct2/show/NCT05130268. Accessed February 4, 2022. 6. AHA Press Release: New heart clinical trial to shine light on early atrial fibrillation
treatment. October 26, 2021. Available at: https://newsroom.heart.org/news/new-heart-clinical-trial-to-shine-light-on-early-atrial-fibrillation-treatment. Accessed
February 4, 2022. 7. Multaq (dronedarone hydrochloride) Prescribing Information. Sanofi-Aventis U.S. LLC: Bridgewater, NJ. 8. CHANGE AFib Webinar (12/06/21).
Available at: https://changeafib.org/webinar-12-06-21. Accessed February 18, 2022. 9. CHANGE AFib Trial Protocol. Version 19. October 29, 2021. Data on File.