Phase 2
Completed N=66
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
Source: ClinicalTrials.gov NCT04571385 ↗Enrolled (actual)
66
Serious AEs
6.4%
Results posted
May 2024
Primary outcomePrimary: Percentage of Participants Who Converted From Atrial Fibrillation (AF) Within 90 Minutes From Start of Infusion and Subsequently Had no AF Recurrence Within 1 Minute of Conversion From AF — 0; 41.7; 54.5 Percentage of participants
Summary
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one or more doses of AP30663 for cardioversion in adult participants with AF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Converted From Atrial Fibrillation (AF) Within 90 Minutes From Start of Infusion and Subsequently Had no AF Recurrence Within 1 Minute of Conversion From AF |
0; 41.7; 54.5 | — |
| SECONDARY Time to Conversion From Atrial Fibrillation From Start of Infusion |
42.0; 35.0 | — |
| SECONDARY Percentage of Participants With Relapse of AF Within 5 Minutes (IRAF) After Pharmacological or Direct Current (DC) Cardioversion |
4.0; 0; 0 | — |
| SECONDARY Percentage of Participants With Sinus Rhythm (SR) at 3 Hours, 24 Hours and Day 30 After Start of Infusion |
84.0; 100.0; 95.2; 76.0; 100.0; 100.0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
13; 4; 11; 4; 0; 0 | — |
| SECONDARY Changes From Baseline in Fridericia's Correction of QT Interval (ΔQTcF) Interval Data Over Time |
1.9; 11.7; 21.2; 1.0; 19.4; 37.7 | — |
| SECONDARY Maximum Observed Peak Plasma Concentration (Cmax) of AP30663 |
7606.065; 10281.754 | — |
| SECONDARY Time to Reach Peak Plasma Concentration (Tmax) of AP30663 |
0.4170; 0.4170 | — |
| SECONDARY Terminal Half Life of (T1/2) of AP30663 |
5.363; 5.620 | — |
| SECONDARY Area Under the Concentration Time Curve From Pre-dose Concentration up to 30 Minutes (AUC0-0.5) of AP30663 |
2568.175; 3446.078 | — |
| SECONDARY Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUC0-t) of AP30663 |
19328.384; 29587.109 | — |
| SECONDARY Area Under the Concentration-Time Curve From Pre-dose (Zero) Through Concentration to Infinity (AUC0-inf) of AP30663 |
21623.095; 31448.932 | — |
| SECONDARY Elimination Rate Constant (Kel) of AP30663 |
0.13092; 0.11817 | — |
Eligibility Criteria
Key Inclusion Criteria
- Clinical indication for cardioversion of AF
- Current episode of symptomatic AF lasting between 3-hour and 7 days (inclusive) at randomization
- Adequate anticoagulation according to international and/or national guidelines
Key Exclusion Criteria
- Significant clinical illness or surgical procedure within 4 weeks preceding the screening visit
- History of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease, sinus nodal disease, or other significant disease, as judged by the investigator.
- Any cardioversion attempt of AF or atrial flutter within 4 weeks preceding randomization
- Use of any antiarrhythmic drug class I and/or III within 6 months before randomisation
Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04571385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.