Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
END-AF-1
2 other identifiers
interventional
200
7 countries
38
Brief Summary
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2025
CompletedFirst Submitted
Initial submission to the registry
November 25, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 5, 2025
November 1, 2025
1 year
November 25, 2025
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Atrial fibrillation burden
Measured through implantable loop recorder. Calculated as the amount of time with AF relative to the amount of time the participant is under observation (expressed as a %).
From week 2 to week 12
Secondary Outcomes (3)
Number of atrial fibrillation episodes
From week 2 to week 12
Change from baseline in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT)
Week 12
Number of ventricular tachycardia episodes > 30 seconds of duration
From week 0 to week 12
Study Arms (5)
AP31969 100 mg
EXPERIMENTALTablets, Twice daily, 12 Weeks
AP31969 200 mg
EXPERIMENTALTablets, Twice daily, 12 Weeks
AP31969 350 mg
EXPERIMENTALTablets, Twice daily, 12 Weeks
AP31969 500 mg
EXPERIMENTALTablets, Twice daily, 12 Weeks
Placebo
PLACEBO COMPARATORTablets, Twice daily, 12 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acesion Pharmalead
Study Sites (38)
UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology
Plovdiv, PD, 4002, Bulgaria
Acibadem City Clinic, Cardiology Department
Sofia, SOF, 1000, Bulgaria
MHAT National Cardiology Hospital EAD, Cardiology Department
Sofia, SOF, 1365, Bulgaria
Aleksandrovska University Hospital, Clinic of Cardiology
Sofia, SOF, 1431, Bulgaria
SHATC Cardiolife, Invasive Cardiology
Varna, VAR, 9000, Bulgaria
Medical Center Nova Clinic
Varna, VAR, 9020, Bulgaria
University Hospital Herlev and Gentofte Department of Cardiology
Hellerup, 2730, Denmark
Viborg Hospital, Department of Cardiology
Viborg, 8800, Denmark
Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin
Coburg, 96450, Germany
Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie
Frankfurt, 60590, Germany
Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie
Hamburg, 20246, Germany
Budai Irgalmasrendi Kórház
Budapest, 1023, Hungary
Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika
Budapest, 1122, Hungary
Soproni Gyógyközpont Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet
Sopron, 9400, Hungary
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika
Szeged, 6725, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet
Szolnok, 5000, Hungary
Belvárosi Egészségház, Platán Magánklinika
Zalaegerszeg, 8900, Hungary
Policlinico Sant'Orsola Cardiology Department
Bologna, BO, 40138, Italy
Arcispedale Sant'Anna, Cardiology Department
Cona, FE, 444124, Italy
ASST Grande Ospedale Metropolitano Niguarda Cardiology 3 - Electrophysiology "De Gasperis" Cardio Center
Milan, Michigan, 20162, Italy
University of Modena and Reggio Emilia, Policlinico di Modena, Cardiology Department
Modena, Missouri, 30174, Italy
Dell'Angelo Hospital, Cardiology Department
Mestre, VE, 30174, Italy
Rijnstate Ziekenhuis, Cardiology Department
Arnhem, 6815 AD, Netherlands
Deventer Ziekenhuis, Cardiology Department
Deventer, 7416 SE, Netherlands
Martini Hospital Groningen, Cardiology Department
Groningen, 9728 NT, Netherlands
Spaarne Gasthuis, Cardiology Department
Haarlem, 2035 RC, Netherlands
Frisius MC Leeuwarden, Hart- en Vaatcentrum
Leeuwarden, 8934 AD, Netherlands
Maastricht University Medical Center, Cardiology Department
Maastricht, 6229 HX, Netherlands
HagaZiekenhuis, Cardiology/Electrophysiology Unit
The Hague, 2545 AA, Netherlands
Rivierenland Hospital, Cardiology Department
Tiel, 4002 WP, Netherlands
Máxima Medisch Centrum, Cardiology Department
Veldhoven, 5504 DB, Netherlands
Centrum Medyczne KERmed Cardiology Department
Bydgoszcz, 85-231, Poland
Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej
Chrzanów, 85-231, Poland
Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, 41-300, Poland
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-635, Poland
Upper-Silesian Medical Center 2nd Department of Cardiology
Katowice, 40-635, Poland
One Day Med Sp. z o.o. Clinical Trials Department
Szczecin, 70-419, Poland
Polsko-Amerykańskie Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im
Tychy, 43-100, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Also the blinded CRO team will not be made aware of the treatment group assignment during the trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2025
First Posted
December 5, 2025
Study Start
October 22, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
Qualified external researchers may request access to anonymized data and needed trial documentation. Requests are evaluated on the basis of scientific merit. Any use of and access to the data must respect the privacy of the participants and will only be provided if applicable laws and regulations allow this.