AP31969 versus placebo to control heart rhythm in people with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-arm Phase 2 trial comparing multiple oral doses of AP31969 to placebo over a 12-week treatment period with a 30-day follow-up. Participants will be implanted with a loop recorder to continuously measure AF burden and will attend scheduled visits for ECGs, blood and urine tests, and safety monitoring. Eligible adults must have documented paroxysmal or persistent AF with an expected AF burden between 1% and 90% at screening and agree to avoid other rhythm-control interventions during the trial. Doses being tested include 100 mg, 200 mg, 350 mg (and a later 500 mg cohort may be added), all given twice daily.

Why it matters

Who can join: the full rules

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.

Where it's running

• UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology
  Plovdiv, Pd, Bulgaria Recruiting
• Acibadem City Clinic, Cardiology Department
  Sofia, Sof, Bulgaria Recruiting
• Aleksandrovska University Hospital, Clinic of Cardiology
  Sofia, Sof, Bulgaria Recruiting
• SHATC Cardiolife, Invasive Cardiology
  Varna, Var, Bulgaria Recruiting
• Medical Center Nova Clinic
  Varna, Var, Bulgaria Recruiting
• University Hospital Herlev and Gentofte Department of Cardiology
  Hellerup, Denmark Recruiting

Study contacts

• Study coordinator: Birgitte Vestbjerg
• Email: bve@acesionpharma.com
• Phone: +0045 2077 2575

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.