Tests AP31969 against placebo for irregular heartbeat control
Tests AP31969 against a placebo in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
Key facts
- Where
- Bergamo, Bologna, Ferrara, Milan, Modena, and Venice, ItalySee the 7 sites
- Phase
- Phase 2
Where in Italy
- Cliniche Gavazzeni S.p.A.Bergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ulss 3 SerenissimaVenice, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Acesion Pharma
- Trial code
- NCT07267949EU 2025-521377-14-00
- Record updated
- 30 September 2026
- Original description
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.Read full original descriptionShow less
Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Inclusion: 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: 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; Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to the screening visit; 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); Clinically significant valvular heart disease, including severe aortic stenosis, severe mitral regurgitation and/or severe mitral stenosis, in the opinion of the investigator; Left ventricular ejection fraction < 40% based on imaging (e.g. echocardiography) performed within 6 months prior to or during the screening visit; 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.