Status:
RECRUITING
Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
Lead Sponsor:
Acesion Pharma
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Detailed Description
The key goal of this clinical trial is to assess the effectiveness of different doses of AP31969 in lowering Atrial Fibrillation (AF) burden and its safety. Participants will be randomly assigned to ...
Eligibility Criteria
Inclusion Criteria:
-
Willing and able to provide written informed consent.
-
Age 18 or older.
-
ECG documented diagnosis of paroxysmal or persistent AF.
-
AF history at screening indicating an expected AF burden of 1-90%, i.e., at least 1 self-terminating AF episode within 4 months prior to the screening visit.
-
AF burden of ≥ 1% and ≤ 90% assessed with an ECG patch device during the screening period prior to the randomisation visit.
-
Investigator and participant agreement to avoid non-trial related rhythm control intervention for the duration of the trial, including:
- Antiarrhythmic drug class I and/or III (including amiodarone)
- Electrical or pharmacological cardioversion
- AF ablation procedure
-
Willing to have a loop recorder implanted.
Exclusion Criteria:
- Prior AF ablation procedure other than pulmonary vein isolation (PVI) only.
- Any of the following events within 4 weeks prior to the screening visit: Myocardial infarction, Unstable angina pectoris, Stroke or transient, ischaemic attack, Percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG), Peripheral revascularisation procedure.
- Cardiac pacing device e.g. pacemaker and cardiac resynchronization therapy device with atrial or ventricular pacing for > 5% of the time or existing implantable loop recorder.
- Heart failure, New York Heart Association class III (3) or IV (4).
- Left ventricular ejection fraction < 40% based on imaging (e.g. echocardiography) performed within 6 months prior to or during the screening visit.
- Clinically significant valvular heart disease, including severe aortic stenosis, severe mitral regurgitation and/or severe mitral stenosis, in the opinion of the investigator.
- QTc (Fridericia, QTcF) interval > 450 ms for males and > 470 ms for females at screening.
- eGFR <60 mL/min /1.73 m² based on creatine and CKD-EPI formula
- Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to the screening visit.
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07267949
Start Date
October 22 2025
End Date
December 1 2026
Last Update
December 5 2025
Active Locations (38)
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1
UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology
Plovdiv, PD, Bulgaria, 4002
2
Acibadem City Clinic, Cardiology Department
Sofia, SOF, Bulgaria, 1000
3
MHAT National Cardiology Hospital EAD, Cardiology Department
Sofia, SOF, Bulgaria, 1365
4
Aleksandrovska University Hospital, Clinic of Cardiology
Sofia, SOF, Bulgaria, 1431