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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Page 1 of 10 (38 locations)

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

Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation | DecenTrialz