Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07267949

PHASE2

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

Sponsor: Acesion Pharma

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-10-22

Completion Date

2026-12

Last Updated

2025-12-05

Healthy Volunteers

Conditions

Atrial Fibrillation (AF)

Interventions

DRUG

AP31969

Tablets, Oral, Twice daily.

DRUG

Placebo

Tablets, oral, Twice daily.

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.

Locations (38)

UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology

Plovdiv, PD, Bulgaria

Acibadem City Clinic, Cardiology Department

Sofia, SOF, Bulgaria

MHAT National Cardiology Hospital EAD, Cardiology Department

Sofia, SOF, Bulgaria

Aleksandrovska University Hospital, Clinic of Cardiology

Sofia, SOF, Bulgaria

SHATC Cardiolife, Invasive Cardiology

Varna, VAR, Bulgaria

Medical Center Nova Clinic

Varna, VAR, Bulgaria

University Hospital Herlev and Gentofte Department of Cardiology

Hellerup, Denmark

Viborg Hospital, Department of Cardiology

Viborg, Denmark

Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin

Coburg, Germany

Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie

Frankfurt, Germany

Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie

Hamburg, Germany

Budai Irgalmasrendi Kórház

Budapest, Hungary

Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika

Budapest, Hungary

Soproni Gyógyközpont Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet

Sopron, Hungary

Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika

Szeged, Hungary

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet

Szolnok, Hungary

Belvárosi Egészségház, Platán Magánklinika

Zalaegerszeg, Hungary

Policlinico Sant'Orsola Cardiology Department

Bologna, BO, Italy

Arcispedale Sant'Anna, Cardiology Department

Cona, FE, Italy

ASST Grande Ospedale Metropolitano Niguarda Cardiology 3 - Electrophysiology "De Gasperis" Cardio Center

Milan, Michigan, Italy

University of Modena and Reggio Emilia, Policlinico di Modena, Cardiology Department

Modena, Missouri, Italy

Dell'Angelo Hospital, Cardiology Department

Mestre, VE, Italy

Rijnstate Ziekenhuis, Cardiology Department

Arnhem, Netherlands

Deventer Ziekenhuis, Cardiology Department

Deventer, Netherlands

Martini Hospital Groningen, Cardiology Department

Groningen, Netherlands

Spaarne Gasthuis, Cardiology Department

Haarlem, Netherlands

Frisius MC Leeuwarden, Hart- en Vaatcentrum

Leeuwarden, Netherlands

Maastricht University Medical Center, Cardiology Department

Maastricht, Netherlands

HagaZiekenhuis, Cardiology/Electrophysiology Unit

The Hague, Netherlands

Rivierenland Hospital, Cardiology Department

Tiel, Netherlands

Máxima Medisch Centrum, Cardiology Department

Veldhoven, Netherlands

Centrum Medyczne KERmed Cardiology Department

Bydgoszcz, Poland

Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej

Chrzanów, Poland

Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

Dąbrowa Górnicza, Poland

Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, Poland

Upper-Silesian Medical Center 2nd Department of Cardiology

Katowice, Poland

One Day Med Sp. z o.o. Clinical Trials Department

Szczecin, Poland

Polsko-Amerykańskie Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im

Tychy, Poland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (38)