Clinical trial • Phase II • Cardiology

AP31969 SULFATE for Atrial fibrillation

Phase II trial of AP31969 SULFATE for Atrial fibrillation.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Atrial fibrillation
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-06-2025
First CTIS Authorization Date
29-09-2025

Trial design

Randomised, placebo, oral bid for 12 weeks; comparator arms include ap31969 100 mg oral bid for 12 weeks, ap31969 200 mg oral bid for 12 weeks, ap31969 350 mg oral bid for 12 weeks, ap31969 500 mg oral bid for 12 weeks.-controlled, adaptive Phase II trial across 38 sites in Denmark, Germany, Hungary and others.

Randomised
Yes
Comparator
Placebo, oral BID for 12 weeks; comparator arms include AP31969 100 mg oral BID for 12 weeks, AP31969 200 mg oral BID for 12 weeks, AP31969 350 mg oral BID for 12 weeks, AP31969 500 mg oral BID for 12 weeks.
Adaptive
True (study includes a dose escalation phase of 12 days at start of treatment period followed by a 10-week + 2-day maintenance phase; randomisation is 1:1:1:1:1 across predefined dose arms and placebo; no detailed interim analysis or stopping rules are described in the provided record).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
180
Trial Duration For Participant
142

Stratification factors

  • Baseline AF burden (< 10% vs ≥ 10% recorded by patch device during screening)

Eligibility

Recruits 180 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be willing and able to provide written informed consent. No specific assent process for minors is described (study restricts enrollment to age 18 or older)..

Pregnancy Exclusion
Female participants must not be pregnant or breastfeeding. Female participants of childbearing potential who have a fertile male sexual partner must agree to use highly effective contraception and not donate ova from 4 weeks prior to the first trial drug administration and until the follow-up visit. Male participants, if not surgically sterilized, who have a female sexual partner of childbearing potential, must agree to use a condom and not donate sperm from the screening visit until the follow-up visit.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be willing and able to provide written informed consent. No specific assent process for minors is described (study restricts enrollment to age 18 or older).

Inclusion criteria

  • {"criterion_text":"- Willing and able to provide written informed consent."}
  • {"criterion_text":"- Age 18 or older."}
  • {"criterion_text":"- ECG documented diagnosis of AF."}
  • {"criterion_text":"- AF history at screening indicating an expected AF burden of 1-90%."}
  • {"criterion_text":"- If currently in AF, the episode must be of < 7 days duration at screening."}
  • {"criterion_text":"- AF burden of ≥ 1% and ≤ 90% assessed with an ECG patch device."}
  • {"criterion_text":"- Agreement to avoid non-trial related rhythm control intervention for the duration of the trial."}
  • {"criterion_text":"- Willing to have a loop recorder implanted."}
  • {"criterion_text":"- Female participants must not be pregnant or breastfeeding. Female participants of childbearing potential who have a fertile male sexual partner must agree to use highly effective contraception and not donate ova from 4 weeks prior to the first trial drug administration and until the follow-up visit. Male participants, if not surgically sterilized, who have a female sexual partner of childbearing potential, must agree to use a condom and not donate sperm from the screening visit until the follow-up visit."}

Exclusion criteria

  • {"criterion_text":"- Prior AF ablation procedure (treatment that uses heat or cold energy to create tiny scars in an area of the heart)."}
  • {"criterion_text":"- Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to screening."}
  • {"criterion_text":"- Use of QT-prolonging drug within 7 days prior to screening."}
  • {"criterion_text":"- Significant cardiovascular events."}
  • {"criterion_text":"- Use of a moderate or strong inhibitor of cytochrome P450 (CYP) 3A4 within 7 days prior to screening."}
  • {"criterion_text":"- Received non-marketed or drug in a clinical trial within 30 days or 5 half-lives prior to screening."}
  • {"criterion_text":"- Administration of AP31969 at any time prior to screening."}
  • {"criterion_text":"- History of significant mental, renal or hepatic disorder, or other significant disease."}
  • {"criterion_text":"- Planned or expected major cardiovascular or other procedure for the duration of the trial."}
  • {"criterion_text":"- Cardiac pacing device, e.g., pacemaker."}
  • {"criterion_text":"- Uncontrolled high blood pressure."}
  • {"criterion_text":"- QTc interval > 450 ms for males and > 470 ms for females."}
  • {"criterion_text":"- Heart failure."}
  • {"criterion_text":"- Left ventricular ejection fraction (how much blood is pumped from the heart < 40%."}
  • {"criterion_text":"- Clinically significant heart valve disease."}
  • {"criterion_text":"- Personal or 1st degree family history of certain heart diseases."}
  • {"criterion_text":"- History of drug addiction and/or alcohol abuse."}
  • {"criterion_text":"- Any malignant cancer (except for in-situ non-melanoma skin cancer, breast ductal carcinoma in-situ and in-situ cervical cancer) within 2 years prior to screening."}
  • {"criterion_text":"- QRS duration >120 ms at screening."}
  • {"criterion_text":"- Sick sinus syndrome (heart rhythm disorder)."}
  • {"criterion_text":"- Atrioventricular block or complete bundle branch block (heart rhythm disorders)."}
  • {"criterion_text":"- Reduced kidney function."}
  • {"criterion_text":"- Increase of liver enzymes."}
  • {"criterion_text":"- Thyroid-stimulating hormone below 0.5 or above 5.0 mIU/L"}
  • {"criterion_text":"- Potassium below 3.5 or above 5.3 mmol/L."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- AF burden from week 2 to week 12.","definition_or_measurement_approach":"AF burden assessed during the treatment period (week 2 to week 12) using continuous cardiac monitoring (ECG patch device during screening and implantable loop recorder implantation at/around randomisation as specified in protocol)."}

Secondary endpoints

  • {"endpoint_text":"- •\tNumber of AF episodes from week 2 to week 12 •\tMean duration of AF episodes from week 2 to week 12 •\tTime to first AF episode > 5 hours (for participants in sinus rhythm [SR] at randomisation)","definition_or_measurement_approach":"AF episode counts, durations and time-to-event measured from continuous monitoring (ECG patch / implantable loop recorder) from week 2 to week 12."}
  • {"endpoint_text":"- •\tChange from baseline in Modified European Heart Rhythm Association (mEHRA) score at week 12","definition_or_measurement_approach":"Change in mEHRA symptom severity score from baseline to week 12 assessed by clinical evaluation/questionnaire."}
  • {"endpoint_text":"- •\tChange from baseline in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire at week 12 •\tChange from baseline in EQ-5D-5L score at week 12 •\tPatient Global Assessment of Change (PGI-C) score at week 12","definition_or_measurement_approach":"Patient-reported outcomes measured by validated questionnaires (AFEQT, EQ-5D-5L, PGI-C) comparing baseline to week 12."}
  • {"endpoint_text":"- •\tAdverse events (AE) •\tNumber of ventricular tachycardia episodes > 30 seconds of duration from week 0 to week 12 •\tChange from baseline in QTcF at week 12","definition_or_measurement_approach":"Safety endpoints collected via AE reporting; ventricular tachycardia episodes detected by monitoring (device/ECG); QTcF measured by ECG with Fridericia correction at scheduled visits."}

Recruitment

Planned Sample Size
180
Recruitment Window Months
14
Consent Approach
Written informed consent required from each participant ('Willing and able to provide written informed consent'). Participants are adults (age 18+). Informed consent documents (ICF / patient information) are provided in country-specific languages as per submitted documents (examples include English, Hungarian, Italian, Dutch, Polish, German, Bulgarian, Danish). No specific assent procedures for minors are described (min age 18).

Geography

Total Number Of Sites
38
Total Number Of Participants
180

Denmark

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
10
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Gentofte Hospital
Department Name
Department of Cardiology
Contact Person Name
Tor Biering-Sorensen
Site Name
Region Midtjylland
Department Name
Department of Cardiology
Contact Person Name
Andi Albertsen
Contact Person Email
andialbe@rm.dk

Germany

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
19
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
SANA Kliniken Oberfranken Coburg GmbH
Department Name
Department of Cardiology
Contact Person Name
Mathias Forkmann
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Cardiology
Contact Person Name
Paulus Kirchhof
Contact Person Email
p.kirchhof@uke.de
Site Name
Goethe University Frankfurt
Department Name
Department of Cardiology
Contact Person Name
Reza Wakili
Contact Person Email
reza.wakili@herz-frankfurt.de

Hungary

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
13
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Belvarosi Egeszseghaz Kft.
Department Name
Cardiology Department
Contact Person Name
Geza Lupkovics
Contact Person Email
lupkogeza@t-online.hu
Site Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Department Name
Cardiology Department
Contact Person Name
Előd Papp
Contact Person Email
pappelod@gmail.com
Site Name
Soproni Erzsebet Oktato Korhaz Es Rehabilitacios Intezet
Department Name
Cardiology-Internal Medicine Department
Contact Person Name
Krisztina Hati
Site Name
University Of Szeged
Department Name
Cardiology Center
Contact Person Name
Tamás Szili-Török
Site Name
Semmelweis University
Department Name
Heart and Vascular Clinic
Contact Person Name
Béla Merkely
Site Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Department Name
Cardiology Department
Contact Person Name
János Tomcsányi
Contact Person Email
tomcsanyij@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
19
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
American Heart Of Poland S.A.
Department Name
Oddział Intensywnej Opieki Kardiologicnej
Contact Person Name
Aleksander Żurkowski
Contact Person Email
olekzurakowski@gmail.com
Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
Odział Elektrokardiologii
Contact Person Name
Krzysztof Gołba
Contact Person Email
bfdzial@gcm.pl
Site Name
One Day Med Sp. z o.o.
Contact Person Name
Benita Busz-Papież
Contact Person Email
abieganska@domlekarski.pl
Site Name
NZOZ Centrum Medyczne KERmed
Contact Person Name
Michał Szymczak
Contact Person Email
ewa.kowalinska@kermed.pl
Site Name
American Heart Of Poland S.A.
Department Name
X Odział Kardiologi Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im. Macieja Pruskieg
Contact Person Name
Adam Janas
Contact Person Email
adam.janas@ahop.pl
Site Name
American Heart Of Poland S.A.
Department Name
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektroradiologii
Contact Person Name
Katarzyna Szymczyk
Contact Person Email
katarzyna.szymczyk@ahop.pl
Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
II Oddział Kardiologii
Contact Person Name
Grzegorz Smolka
Contact Person Email
bfdzial@gcm.pl

Italy

Earliest CTIS Part Ii Submission Date
25-06-2025
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
99
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
University Hospital Of Ferrara
Department Name
Cardiologia
Contact Person Name
Matteo Bertini
Contact Person Email
brtmtt2@unife.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento di Medicina sperimentale, diagnostica e specialistica, Istituto di Cardiologia
Contact Person Name
Igor Diemberger
Contact Person Email
igor.diemberger@unibo.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Cardiologia
Contact Person Name
Matteo Baroni
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Cardiologia
Contact Person Name
Giuseppe Boriani
Contact Person Email
giuseppe.boriani@unimore.it
Site Name
Azienda Ulss 3 Serenissima
Department Name
Cardiologia
Contact Person Name
Sakis Themistoclakis

Netherlands

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
33
Number Of Sites
9
Number Of Participants
40

Sites

Site Name
Haga Hospital
Department Name
Cardiology Department
Contact Person Name
Vincent van Driel
Contact Person Email
v.vandriel@hagaziekenhuis.nl
Site Name
Deventer Ziekenhuis
Department Name
Cardiology Department
Contact Person Name
Ype Tuininga
Contact Person Email
e.badings@dz.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Cardiology Department
Contact Person Name
Robert Tieleman
Contact Person Email
r.tieleman@gmail.com
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Cardiology Department
Contact Person Name
Martin Hemels
Contact Person Email
MHemels@rijnstate.nl
Site Name
Maxima Medisch Centrum
Department Name
Cardiology Department
Contact Person Name
Sabine Eijsbouts
Contact Person Email
i.groenenberg@mmc.nl
Site Name
Ziekenhuis Rivierenland
Department Name
Cardiology Department
Contact Person Name
Harvey Fijn
Contact Person Email
h.fijn@zrt.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Cardiology Department
Contact Person Name
Laurens Swart
Site Name
Frisius MC
Department Name
Hart- en Vaatcentrum
Contact Person Name
Karin Kraaier
Contact Person Email
metske.wal@mcl.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Cardiology
Contact Person Name
Dominik Linz
Contact Person Email
Dominik.Linz@mumc.nl

Bulgaria

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
06-11-2025
Processing Time Days
45
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
MHAT National Heart Hospital EAD
Department Name
Cardiology Department
Contact Person Name
Alexander Alexandrov
Contact Person Email
hristina.stoynova@clineca.net
Site Name
Specialized Hospital For Active Cardiology Treatement Cardiolife OOD
Department Name
Cardiology
Contact Person Name
Trayan Tsvetkov
Site Name
Alexandrovska University Hospital
Department Name
Clinic of Cardiology
Contact Person Name
Kiril Karamfiloff
Contact Person Email
dr.kiril.karamfilov@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Department of Invasive Cardiology
Contact Person Name
Georgi Goranov
Contact Person Email
dr.georgi.goranov@gmail.com
Site Name
Medcenter Nova Clinic Ltd.
Department Name
Cardiology Department
Contact Person Name
Sofiya Petrova
Contact Person Email
dr.sophia.petrova@abv.bg
Site Name
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
Department Name
Cardiology Department
Contact Person Name
Zoran Stankov

Sponsor

Primary sponsor

Full Name
Acesion Pharma ApS
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Pharmacovigilance
Name
Opis S.r.l.
Responsibilities
Management of trial documentation (eTMF); management of contracts with institution; other operational sponsor duties (sponsorDuties codes present)

Third parties

  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"sponsorDuties codes: 1, 11, 12, 15 (Management of Trial documentation (eTMF)), 15 (Management of Contracts with Institution), 5, 6","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Medtronic B.V.","duties_or_roles":"sponsorDuties code: 15 (supply of ILR device)","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"central laboratory testings","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Denmark","full_name":"Cortrium ApS","duties_or_roles":"sponsorDuties code: 15 (supply of ECG patch device)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Cardiabase","duties_or_roles":"central reading","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l. (additional address)","duties_or_roles":"sponsorDuties code: 14 (duplicate/another entry)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AP31969
Active Substance
AP31969 SULFATE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus: 1
Starting Dose
100 mg
Dose Levels
100 mg | 200 mg | 350 mg | 500 mg
Frequency
BID
Maximum Dose
500 mg per dose (1000 mg daily)
Investigational Product Name
The placebo tablets contain the same excipient as in the active IMP, but without AP31969. All tablet strengths containing AP31969 as well as placebo tablets are visually identical.
Modality
Other
Routes Of Administration
Oral
Route
Oral
Frequency
BID

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