Arrhythmias & electrophysiologyRandomised controlled trial
Inhibition of the KCa2 potassium channel in atrial fibrillation: a randomized phase 2 trial
- Randomised controlled trial
- phase 2
- placebo-controlled
- prematurely discontinued
- Bayesian analysis
Trial prematurely discontinued because of slow enrollment during the COVID pandemic
Authors' conclusion
AP30663 demonstrated AF cardioversion efficacy in patients with recent-onset AF episodes.
Study context
- Population
- Patients with a current episode of atrial fibrillation (AF) lasting 7 days or lessrandomised, in efficacy analyses
- Participants
- 59 patients
- Comparison
- AP30663 3 or 5 mg kg-1 IV vs placebo
- 3 mg kg-1 AP30663n = 12
- 5 mg kg-1 AP30663n = 22
- Placebon = 25reference
- Primary endpoint
- Cardioversion from AF to sinus rhythm
- Follow-up
- Within 90 min from the start of the infusion
Primary result
As reported in the abstract
- Both doses: probability of superiority over placebo (prespecified threshold 95%)
- more than 99.9%
Secondary outcomes
Mean, minutes
| Outcome | 3 mg kg-1 AP30663 | 5 mg kg-1 AP30663 | Placebo |
|---|---|---|---|
| Time to cardioversion | 47 (SD 23) | 41 (SD 24) | Not reported in the abstract |
Safety
| Outcome | 3 mg kg-1 AP30663 | 5 mg kg-1 AP30663 | Placebo |
|---|---|---|---|
| QTcF interval (transient increase) | Not reported in the abstract | maximum mean effect 37.7 ms | Not reported in the abstract |
Ventricular arrhythmias and adverse events
- No ventricular arrhythmias in either dose group
- Adverse event rates comparable to placebo
Original publication
Inhibition of the KCa2 potassium channel in atrial fibrillation: a randomized phase 2 trial. Nat Med. Published 13 December 2023. doi:10.1038/s41591-023-02679-9
Summarised from the published abstract; every number is checked against it