Atrial Fibrillation (AF)Phase 2END-AF-1NCT07267949
Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
A Phase 2 study testing AP31969 in people with Atrial Fibrillation (AF), run by Acesion Pharma at 46 sites in 8 countries.
Trial summary
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- AP31969
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 46 sitesin 8 countries
- Study dates
- 22 Oct 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Antiarrhythmic drug class I and/or III (including amiodarone)
- Electrical or pharmacological cardioversion
- AF ablation procedure
- Willing to have a loop recorder implanted.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
46 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 8 countries
Netherlands9 sites, 7 recruiting
- Recruiting
Rijnstate Ziekenhuis, Cardiology Department
Arnhem, 6815 AD
- Recruiting
Deventer Ziekenhuis, Cardiology Department
Deventer, 7416 SE
- Recruiting
Martini Hospital Groningen, Cardiology Department
Groningen, 9728 NT
- Recruiting
Spaarne Gasthuis, Cardiology Department
Haarlem, 2035 RC
- Withdrawn
Frisius MC Leeuwarden, Hart- en Vaatcentrum
Leeuwarden, 8934 AD
- Active, not recruiting
Maastricht University Medical Center, Cardiology Department
Maastricht, 6229 HX
- Recruiting
HagaZiekenhuis, Cardiology/Electrophysiology Unit
The Hague, 2545 AA
- Recruiting
Rivierenland Hospital, Cardiology Department
Tiel, 4002 WP
- Recruiting
Máxima Medisch Centrum, Cardiology Department
Veldhoven, 5504 DB
Hungary7 sites, 6 recruiting
- Recruiting
Budai Irgalmasrendi Kórház
Budapest, 1023
- Recruiting
Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika
Budapest, 1122
- Not yet recruiting
Pécsi Tudományegyetem Szivgyógyászati Klinika (Cardiology Clinic, University of Pecs)
Pécs, Hungary, 7622
- Withdrawn
Soproni Gyógyközpont Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet
Sopron, 9400
- Recruiting
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika
Szeged, 6725
- Recruiting
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet
Szolnok, 5000
- Recruiting
Belvárosi Egészségház, Platán Magánklinika
Zalaegerszeg, 8900
Poland7 sites, 7 recruiting
- Recruiting
Centrum Medyczne KERmed Cardiology Department
Bydgoszcz, 85-231
- Recruiting
Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej
Chrzanów, 85-231
- Recruiting
Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, 41-300
- Not yet recruiting
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-635
- Not yet recruiting
Upper-Silesian Medical Center 2nd Department of Cardiology
Katowice, 40-635
- Recruiting
One Day Med Sp. z o.o. Clinical Trials Department
Szczecin, 70-419
- Recruiting
Polsko-Amerykańskie Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im
Tychy, 43-100
Bulgaria6 sites, 5 recruiting
- Recruiting
UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology
Plovdiv, PD, 4002
- Recruiting
Acibadem City Clinic, Cardiology Department
Sofia, SOF, 1000
- Withdrawn
MHAT National Cardiology Hospital EAD, Cardiology Department
Sofia, SOF, 1365
- Recruiting
Aleksandrovska University Hospital, Clinic of Cardiology
Sofia, SOF, 1431
- Recruiting
SHATC Cardiolife, Invasive Cardiology
Varna, VAR, 9000
- Recruiting
Medical Center Nova Clinic
Varna, VAR, 9020
Italy6 sites, 6 recruiting
- Recruiting
Policlinico Sant'Orsola Cardiology Department
Bologna, BO, 40138
- Recruiting
Arcispedale Sant'Anna, Cardiology Department
Cona, FE, 444124
- Recruiting
Dell'Angelo Hospital, Cardiology Department
Mestre, VE, 30174
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda Cardiology 3 - Electrophysiology "De Gasperis" Cardio Center
Milan, 20162
- Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Department of Cardio - Thoracic- Vascular Diseases,
Milan, 20122
- Recruiting
University of Modena and Reggio Emilia, Policlinico di Modena, Cardiology Department
Modena, 30174
Serbia6 sites, 6 recruiting
- Recruiting
Institute for Cardiovascular Disease "Dedinje" Department for Electrophysiology
Belgrade
- Recruiting
University Clinical Centre of Serbia Department for Intensive Care in Arrhythmology
Belgrade
- Recruiting
Institute for Cardiovascular Diseases Vojvodina Department of Interventional Electrophysiology
Kamenitz
- Recruiting
University Clinical Center Kragujevac Clinic of Cardiology (Depar. Electrophysiology)
Kragujevac
- Recruiting
University Clinical Center Nis Clinic for Cardiovascular Diseases Bulevar
Niš
- Recruiting
Health Center Uzice Cardiology Department
Užice, 33100
Germany3 sites, 3 recruiting
- Recruiting
Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin
Coburg, 96450
- Recruiting
Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie
Frankfurt, 60590
- Recruiting
Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie
Hamburg, 20246
Denmark2 sites, 2 recruiting
- Recruiting
University Hospital Herlev and Gentofte Department of Cardiology
Hellerup, 2730
- Recruiting
Viborg Hospital, Department of Cardiology
Viborg, 8800
About this study
Official title: 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.
Read the detailed description
The key goal of this clinical trial is to assess the effectiveness of different doses of AP31969 in lowering Atrial Fibrillation (AF) burden and its safety.
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
- Atrial Fibrillation (AF)
- Being tested
- AP31969, Placebo
- Keywords
- Atrial Fibrillation, AP31969, SK channel inhibitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP31969Drug
Tablets, Oral, Twice daily.
PlaceboDrug
Tablets, oral, Twice daily.
| Study group | Role | What they receive |
|---|---|---|
| AP31969 100 mg | Experimental | Tablets, Twice daily, 12 Weeks Receives: Drug: AP31969 |
| AP31969 200 mg | Experimental | Tablets, Twice daily, 12 Weeks Receives: Drug: AP31969 |
| AP31969 350 mg | Experimental | Tablets, Twice daily, 12 Weeks Receives: Drug: AP31969 |
| AP31969 500 mg | Experimental | Tablets, Twice daily, 12 Weeks Receives: Drug: AP31969 |
| Placebo | Placebo comparator | Tablets, Twice daily, 12 Weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %).
Measured: From week 2 to week 12
Secondary outcomes (3)
Number of atrial fibrillation episodes
Measured through implantable loop recorder.
Measured: From week 2 to week 12
Change from baseline in Atrial Fibrillation Effect on Quality-of-Life
Patient reported outcome. Reporting on a scale of 1 to 7, where 7 is the worse outcome.
Measured: Week 12
Number of ventricular tachycardia episodes > 30 seconds of duration
Measured through implantable loop recorder.
Measured: From week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start22 Oct 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acesion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267949
- Sponsor's protocol ID
- AP31969-M201
- Other IDs
- 2025-521377-14-00, 2025
- Acronym
- END-AF-1
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07267949
- Acronym / sponsor ID
- END-AF-1 / AP31969-M201
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, AP31969, SK channel inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Acesion PharmaIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Detailed description
The key goal of this clinical trial is to assess the effectiveness of different doses of AP31969 in lowering Atrial Fibrillation (AF) burden and its safety.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AP31969 100 mg | Experimental | Drug: AP31969Tablets, Twice daily, 12 Weeks |
| AP31969 200 mg | Experimental | Drug: AP31969Tablets, Twice daily, 12 Weeks |
| AP31969 350 mg | Experimental | Drug: AP31969Tablets, Twice daily, 12 Weeks |
| AP31969 500 mg | Experimental | Drug: AP31969Tablets, Twice daily, 12 Weeks |
| Placebo | Placebo comparator | Drug: PlaceboTablets, Twice daily, 12 Weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP31969Tablets, Oral, Twice daily. | Drug | AP31969 100 mg, AP31969 200 mg, AP31969 350 mg, AP31969 500 mg |
| PlaceboTablets, oral, Twice daily. | Drug | Placebo |
Primary outcome
Atrial fibrillation burden
Time frame: From week 2 to week 12
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 %).
3 secondary outcomes
Number of atrial fibrillation episodes
Time frame: From week 2 to week 12
Change from baseline in Atrial Fibrillation Effect on Quality-of-Life
Time frame: Week 12
Number of ventricular tachycardia episodes > 30 seconds of duration
Time frame: From week 0 to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Atrial Fibrillation (AF)
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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CONVERGE Post-Approval Study (PAS)
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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP31969 in people with Atrial Fibrillation (AF), run by Acesion Pharma at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Netherlands, Hungary, Poland, Bulgaria, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgitte Vestbjerg (+0045 2077 2575, bve@acesionpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation burden (time frame: From week 2 to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.