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Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
EU CTIS ID: 2025-521377-14-00
What this study is testing
To assess the effect of AP31969 on atrial fibrillation (AF) burden.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willing and able to provide written informed consent.
- Age 18 or older.
- ECG documented diagnosis of AF.
- AF history at screening indicating an expected AF burden of 1-90%.
- If currently in AF, the episode must be of < 7 days duration at screening.
- AF burden of ≥ 1% and ≤ 90% assessed with an ECG patch device.
You likely can't join if
- Prior AF ablation procedure (treatment that uses heat or cold energy to create tiny scars in an area of the heart).
- Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to screening.
- Use of QT-prolonging drug within 7 days prior to screening.
- Significant cardiovascular events.
- Use of a moderate or strong inhibitor of cytochrome P450 (CYP) 3A4 within 7 days prior to screening.
- Received non-marketed or drug in a clinical trial within 30 days or 5 half-lives prior to screening.
See the full eligibility criteria
- Willing and able to provide written informed consent.
- Age 18 or older.
- ECG documented diagnosis of AF.
- AF history at screening indicating an expected AF burden of 1-90%.
- If currently in AF, the episode must be of < 7 days duration at screening.
- AF burden of ≥ 1% and ≤ 90% assessed with an ECG patch device.
- Agreement to avoid non-trial related rhythm control intervention for the duration of the trial.
- Willing to have a loop recorder implanted.
- 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.
- Prior AF ablation procedure (treatment that uses heat or cold energy to create tiny scars in an area of the heart).
- Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to screening.
- Use of QT-prolonging drug within 7 days prior to screening.
- Significant cardiovascular events.
- Use of a moderate or strong inhibitor of cytochrome P450 (CYP) 3A4 within 7 days prior to screening.
- Received non-marketed or drug in a clinical trial within 30 days or 5 half-lives prior to screening.
- Administration of AP31969 at any time prior to screening.
- History of significant mental, renal or hepatic disorder, or other significant disease.
- Planned or expected major cardiovascular or other procedure for the duration of the trial.
- Cardiac pacing device, e.g., pacemaker.
- Uncontrolled high blood pressure.
- QTc interval > 450 ms for males and > 470 ms for females.
- Heart failure.
- Left ventricular ejection fraction (how much blood is pumped from the heart < 40%.
- Clinically significant heart valve disease.
- Personal or 1st degree family history of certain heart diseases.
- History of drug addiction and/or alcohol abuse.
- 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.
- QRS duration >120 ms at screening.
- Sick sinus syndrome (heart rhythm disorder).
- Atrioventricular block or complete bundle branch block (heart rhythm disorders).
- Reduced kidney function.
- Increase of liver enzymes.
- Thyroid-stimulating hormone below 0.5 or above 5.0 mIU/L
- Potassium below 3.5 or above 5.3 mmol/L.
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.