Atrial fibrillation
Conditions
Brief summary
AF burden from week 2 to week 12.
Detailed description
• Number of AF episodes from week 2 to week 12 • Mean duration of AF episodes from week 2 to week 12 • Time to first AF episode > 5 hours (for participants in sinus rhythm [SR] at randomisation), • Change from baseline in Modified European Heart Rhythm Association (mEHRA) score at week 12, • Change from baseline in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire at week 12 • Change from baseline in EQ-5D-5L score at week 12 • Patient Global Assessment of Change (PGI-C) score at week 12, • Adverse events (AE) • Number of ventricular tachycardia episodes > 30 seconds of duration from week 0 to week 12 • Change from baseline in QTcF at week 12
Interventions
DRUGAP31969
DRUGThe placebo tablets contain the same excipient as in the active IMP
DRUGbut without AP31969. All tablet strengths containing AP31969 as well as placebo tablets are visually identical.
Sponsors
Acesion Pharma ApS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AF burden from week 2 to week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of AF episodes from week 2 to week 12 • Mean duration of AF episodes from week 2 to week 12 • Time to first AF episode > 5 hours (for participants in sinus rhythm [SR] at randomisation), • Change from baseline in Modified European Heart Rhythm Association (mEHRA) score at week 12, • Change from baseline in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire at week 12 • Change from baseline in EQ-5D-5L score at week 12 • Patient Global Assessment of Change (PGI-C) score at week 12, • Adverse events (AE) • Number of ventricular tachycardia episodes > 30 seconds of duration from week 0 to week 12 • Change from baseline in QTcF at week 12 | — |
Countries
Bulgaria, Denmark, Germany, Hungary, Italy, Netherlands, Poland
Outcome results
None listed