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New pill aims to tame chaotic heartbeats in atrial fibrillation

NCT ID NCT07267949

Disease control Sponsor: Acesion Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether the experimental drug AP31969 can reduce the amount of time people with atrial fibrillation spend in an irregular heart rhythm. Two hundred adults with paroxysmal or persistent AF will receive either AP31969 or a placebo twice daily for several weeks. The main goal is to see if the drug lowers AF burden, measured by a heart monitor, and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AP31969 (oral tablet)
What this could lead to
If successful, this could provide a new oral medication to better control atrial fibrillation and improve quality of life for patients.
What could go wrong
This is an early Phase 2 trial with only 200 participants, so results may not confirm effectiveness or safety. The drug may not reduce AF burden more than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Milan, 20162, Italy

  • Acibadem City Clinic, Cardiology Department

    RECRUITING

    Sofia, SOF, 1000, Bulgaria

  • Aleksandrovska University Hospital, Clinic of Cardiology

    RECRUITING

    Sofia, SOF, 1431, Bulgaria

  • Arcispedale Sant'Anna, Cardiology Department

    RECRUITING

    Cona, FE, 444124, Italy

  • Belvárosi Egészségház, Platán Magánklinika

    RECRUITING

    Zalaegerszeg, 8900, Hungary

  • Budai Irgalmasrendi Kórház

    RECRUITING

    Budapest, 1023, Hungary

  • Centrum Medyczne KERmed Cardiology Department

    RECRUITING

    Bydgoszcz, 85-231, Poland

  • Dell'Angelo Hospital, Cardiology Department

    RECRUITING

    Mestre, VE, 30174, Italy

  • Deventer Ziekenhuis, Cardiology Department

    RECRUITING

    Deventer, 7416 SE, Netherlands

  • Frisius MC Leeuwarden, Hart- en Vaatcentrum

    RECRUITING

    Leeuwarden, 8934 AD, Netherlands

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

    NOT_YET_RECRUITING

    Katowice, 40-635, Poland

  • HagaZiekenhuis, Cardiology/Electrophysiology Unit

    NOT_YET_RECRUITING

    The Hague, 2545 AA, Netherlands

  • Health Center Uzice Cardiology Department

    NOT_YET_RECRUITING

    Užice, 33100, Serbia

  • Institute for Cardiovascular Disease "Dedinje" Department for Electrophysiology

    NOT_YET_RECRUITING

    Belgrade, Serbia

  • Institute for Cardiovascular Diseases Vojvodina Department of Interventional Electrophysiology

    RECRUITING

    Kamenitz, Serbia

  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet

    RECRUITING

    Szolnok, 5000, Hungary

  • MHAT National Cardiology Hospital EAD, Cardiology Department

    WITHDRAWN

    Sofia, SOF, 1365, Bulgaria

  • Maastricht University Medical Center, Cardiology Department

    NOT_YET_RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Martini Hospital Groningen, Cardiology Department

    RECRUITING

    Groningen, 9728 NT, Netherlands

  • Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej

    RECRUITING

    Chrzanów, 85-231, Poland

  • Medical Center Nova Clinic

    RECRUITING

    Varna, VAR, 9020, Bulgaria

  • Máxima Medisch Centrum, Cardiology Department

    RECRUITING

    Veldhoven, 5504 DB, Netherlands

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

    RECRUITING

    Szczecin, 70-419, Poland

  • Policlinico Sant'Orsola Cardiology Department

    RECRUITING

    Bologna, BO, 40138, Italy

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

    RECRUITING

    Dąbrowa Górnicza, 41-300, Poland

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

    RECRUITING

    Tychy, 43-100, Poland

  • Rijnstate Ziekenhuis, Cardiology Department

    RECRUITING

    Arnhem, 6815 AD, Netherlands

  • Rivierenland Hospital, Cardiology Department

    RECRUITING

    Tiel, 4002 WP, Netherlands

  • SHATC Cardiolife, Invasive Cardiology

    RECRUITING

    Varna, VAR, 9000, Bulgaria

  • Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin

    RECRUITING

    Coburg, 96450, Germany

  • Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika

    RECRUITING

    Budapest, 1122, Hungary

  • Soproni Gyógyközpont Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet

    NOT_YET_RECRUITING

    Sopron, 9400, Hungary

  • Spaarne Gasthuis, Cardiology Department

    RECRUITING

    Haarlem, 2035 RC, Netherlands

  • Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika

    RECRUITING

    Szeged, 6725, Hungary

  • UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology

    RECRUITING

    Plovdiv, PD, 4002, Bulgaria

  • Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie

    RECRUITING

    Hamburg, 20246, Germany

  • University Clinical Center Kragujevac Clinic of Cardiology (Depar. Electrophysiology)

    RECRUITING

    Kragujevac, Serbia

  • University Clinical Center Nis Clinic for Cardiovascular Diseases Bulevar

    RECRUITING

    Niš, Serbia

  • University Clinical Centre of Serbia Department for Intensive Care in Arrhythmology

    RECRUITING

    Belgrade, Serbia

  • University Hospital Herlev and Gentofte Department of Cardiology

    RECRUITING

    Hellerup, 2730, Denmark

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

    RECRUITING

    Modena, 30174, Italy

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

    RECRUITING

    Frankfurt, 60590, Germany

  • Upper-Silesian Medical Center 2nd Department of Cardiology

    NOT_YET_RECRUITING

    Katowice, 40-635, Poland

  • Viborg Hospital, Department of Cardiology

    RECRUITING

    Viborg, 8800, Denmark

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