NCT07267949

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Acesion Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DRUG	AP31969	Tablets, Oral, Twice daily.
DRUG	Placebo	Tablets, oral, Twice daily.

Timeline

• Start date: 2025-10-22
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

38 sites across 7 countries: Bulgaria, Denmark, Germany, Hungary, Italy, Netherlands, Poland