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Clinical Trials in Italy / NCT07267949
Recruiting Phase 2

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

NCT07267949 · tracked via the Priya Life Science Italy tracker
Sponsor
Acesion Pharma
Phase
Phase 2
Started
2025-10-22
Last updated
2026-06-12

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

AP31969Placebo

AP31969: Tablets, Oral, Twice daily.

Placebo: Tablets, oral, Twice daily.

Study summary

A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology Plovdiv PD Recruiting
Acibadem City Clinic, Cardiology Department Sofia SOF Recruiting
MHAT National Cardiology Hospital EAD, Cardiology Department Sofia SOF Withdrawn
Aleksandrovska University Hospital, Clinic of Cardiology Sofia SOF Recruiting
SHATC Cardiolife, Invasive Cardiology Varna VAR Recruiting
Medical Center Nova Clinic Varna VAR Recruiting
University Hospital Herlev and Gentofte Department of Cardiology Hellerup Denmark Recruiting
Viborg Hospital, Department of Cardiology Viborg Denmark Recruiting
Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin Coburg Germany Recruiting
Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie Frankfurt Germany Recruiting
Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie Hamburg Germany Recruiting
Budai Irgalmasrendi Kórház Budapest Hungary Recruiting
Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika Budapest Hungary Recruiting
Soproni Gyógyközpont Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet Sopron Hungary Not Yet Recruiting
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika Szeged Hungary Recruiting
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet Szolnok Hungary Recruiting
Belvárosi Egészségház, Platán Magánklinika Zalaegerszeg Hungary Recruiting
Policlinico Sant'Orsola Cardiology Department Bologna BO Recruiting
Arcispedale Sant'Anna, Cardiology Department Cona FE Recruiting
Dell'Angelo Hospital, Cardiology Department Mestre VE Recruiting
ASST Grande Ospedale Metropolitano Niguarda Cardiology 3 - Electrophysiology "De Gasperis" Cardio Center Milan Italy Recruiting
University of Modena and Reggio Emilia, Policlinico di Modena, Cardiology Department Modena Italy Recruiting
Rijnstate Ziekenhuis, Cardiology Department Arnhem Netherlands Recruiting
Deventer Ziekenhuis, Cardiology Department Deventer Netherlands Recruiting
Martini Hospital Groningen, Cardiology Department Groningen Netherlands Recruiting
Spaarne Gasthuis, Cardiology Department Haarlem Netherlands Recruiting
Frisius MC Leeuwarden, Hart- en Vaatcentrum Leeuwarden Netherlands Recruiting
Maastricht University Medical Center, Cardiology Department Maastricht Netherlands Not Yet Recruiting
HagaZiekenhuis, Cardiology/Electrophysiology Unit The Hague Netherlands Not Yet Recruiting
Rivierenland Hospital, Cardiology Department Tiel Netherlands Recruiting
Máxima Medisch Centrum, Cardiology Department Veldhoven Netherlands Recruiting
Centrum Medyczne KERmed Cardiology Department Bydgoszcz Poland Recruiting
Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej Chrzanów Poland Recruiting
Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Dąbrowa Górnicza Poland Recruiting
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Katowice Poland Not Yet Recruiting
Upper-Silesian Medical Center 2nd Department of Cardiology Katowice Poland Not Yet Recruiting
One Day Med Sp. z o.o. Clinical Trials Department Szczecin Poland Recruiting
Polsko-Amerykańskie Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im Tychy Poland Recruiting
Institute for Cardiovascular Disease "Dedinje" Department for Electrophysiology Belgrade Serbia Not Yet Recruiting
University Clinical Centre of Serbia Department for Intensive Care in Arrhythmology Belgrade Serbia Recruiting

+ 4 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07267949 on ClinicalTrials.gov ↗ ← All trials in Italy