Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
NCT ID: NCT07267949
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-10-22
2026-12-31
Brief Summary
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Detailed Description
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Participants will be randomly assigned to one of the following groups:
* AP31969 at 100 mg, 200 mg, or 350 mg doses
* AP31969 500 mg (not included at the trial start)
* Placebo (inactive treatment and has no active properties). The placebo group serves as the comparator for AP31969. All treatments are given orally, twice daily.
The trial includes 3 periods: screening (up to 4 weeks), treatment (12 weeks), and follow-up (30 days). The duration of the trial for a participant is approximately 20 weeks.
Participants will receive an implantable loop recorder and undergo assessments during the visits at specific times, for example blood and urine analyses, and electrocardiogram.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AP31969 100 mg
Tablets, Twice daily, 12 Weeks
AP31969
Tablets, Oral, Twice daily.
AP31969 200 mg
Tablets, Twice daily, 12 Weeks
AP31969
Tablets, Oral, Twice daily.
AP31969 350 mg
Tablets, Twice daily, 12 Weeks
AP31969
Tablets, Oral, Twice daily.
AP31969 500 mg
Tablets, Twice daily, 12 Weeks
AP31969
Tablets, Oral, Twice daily.
Placebo
Tablets, Twice daily, 12 Weeks
Placebo
Tablets, oral, Twice daily.
Interventions
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AP31969
Tablets, Oral, Twice daily.
Placebo
Tablets, oral, Twice daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Acesion Pharma
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2025-521377-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
AP31969-M201
Identifier Type: -
Identifier Source: org_study_id
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