RecruitingPhase 2NCT07267949
Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
Sponsor
Acesion Pharma
Enrollment
200 participants
Start Date
Oct 22, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a new drug called AP31969 to see if it can help control the heart's rhythm in people with atrial fibrillation (AF) — an irregular heartbeat where the heart beats too fast or erratically. The study uses an implanted heart monitor (loop recorder) to track AF over time.
**You may be eligible if...**
- You are 18 or older
- You have been diagnosed with paroxysmal or persistent atrial fibrillation (confirmed by ECG)
- You have had at least one AF episode in the past 4 months, and your AF burden is between 1% and 90% on monitoring
- You agree to have a small loop recorder device implanted under the skin to track your heart rhythm
- You agree to avoid other rhythm control treatments (such as ablation or other antiarrhythmic drugs) for the duration of the trial
**You may NOT be eligible if...**
- You have had a heart attack, stroke, or heart procedure in the past 4 weeks
- You have heart failure of class III or IV severity, or your heart pumps at less than 40% efficiency
- You have significant heart valve disease
- You already have a pacemaker or loop recorder
- You have kidney disease (eGFR below 60)
- You have a prolonged QT interval on ECG
- You have taken certain antiarrhythmic drugs recently
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGAP31969
Tablets, Oral, Twice daily.
DRUGPlacebo
Tablets, oral, Twice daily.
Locations(38)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07267949
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