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Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation

ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcesion Pharma

About this trial

A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • AP31969

    Drug

    Tablets, Oral, Twice daily.

  • Placebo

    Drug

    Tablets, oral, Twice daily.

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: AP31969 100 mgExperimental treatment 1 intervention
Group B: AP31969 200 mgExperimental treatment 1 intervention
Group C: AP31969 350 mgExperimental treatment 1 intervention
Group D: AP31969 500 mgExperimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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 %).

Time frame
From week 2 to week 12

Secondary outcomes

1

Number of atrial fibrillation episodes

Measured through implantable loop recorder.

Time frame
From week 2 to week 12
2

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.

Time frame
Week 12
3

Number of ventricular tachycardia episodes > 30 seconds of duration

Measured through implantable loop recorder.

Time frame
From week 0 to week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acesion Pharma

Lead sponsor

Source ClinicalTrials.gov
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