Clinical trial NCT04571385: A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
Official title: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study of AP30663 Given Intravenously for Cardioversion in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Acesion Pharma
Sponsor class: INDUSTRY
First posted: 2020-10-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 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
timeFrame: Within 90 minutes from the start of infusion (Day 1)
Secondary outcomes:
measure: Time to Conversion From Atrial Fibrillation From Start of Infusion
timeFrame: From start of infusion (Day 1) up to Day 2
measure: Percentage of Participants With Relapse of AF Within 5 Minutes (IRAF) After Pharmacological or Direct Current (DC) Cardioversion
timeFrame: Within 5 minutes after cardioversion (Day 1)
measure: Percentage of Participants With Sinus Rhythm (SR) at 3 Hours, 24 Hours and Day 30 After Start of Infusion
timeFrame: At 3 hours, 24 hours and Day 30 after start of Infusion (Day 1)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From start of infusion (Day 1) up to follow-up (Day 35)
measure: Changes From Baseline in Fridericia's Correction of QT Interval (ΔQTcF) Interval Data Over Time
timeFrame: Baseline, 15 minutes, 45 minutes, 2 hours, 8 hours and 24 hours post-dose
measure: Maximum Observed Peak Plasma Concentration (Cmax) of AP30663
timeFrame: Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion
measure: Time to Reach Peak Plasma Concentration (Tmax) of AP30663
timeFrame: Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion
measure: Terminal Half Life of (T1/2) of AP30663
timeFrame: Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion
measure: Area Under the Concentration Time Curve From Pre-dose Concentration up to 30 Minutes (AUC0-0.5) of AP30663
timeFrame: Baseline (pre-infusion) and at 5, 15, 25, 30 minutes post-infusion
measure: Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUC0-t) of AP30663
timeFrame: Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion
measure: Area Under the Concentration-Time Curve From Pre-dose (Zero) Through Concentration to Infinity (AUC0-inf) of AP30663
timeFrame: Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion
measure: Elimination Rate Constant (Kel) of AP30663
timeFrame: Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Acesion Pharma Investigational Site 110
city: Copenhagen
country: Denmark
facility: Acesion Pharma Investigational Site 106
city: Hellerup
country: Denmark
facility: Acesion Pharma Investigational Site 108
city: Hillerød
country: Denmark
facility: Acesion Pharma Investigational Site 113
city: Roskilde
country: Denmark
facility: Acesion Pharma Investigational Site 105
city: Budapest
country: Hungary
facility: Acesion Pharma Investigational Site 202
city: Budapest
country: Hungary
facility: Acesion Pharma Investigational Site 203
city: Budapest
country: Hungary
facility: Acesion Pharma Investigational Site 207
city: Budapest
country: Hungary
facility: Acesion Pharma Investigational Site 212
city: Budapest
country: Hungary
facility: Acesion Pharma Investigational Site 213
city: Budapest
country: Hungary
facility: Acesion Pharma Investigational Site 214
city: Pecs
country: Hungary
facility: Acesion Pharma Investigational Site 211
city: Szekszárd
country: Hungary
facility: Acesion Pharma Investigational Site 201
city: Szentes
country: Hungary
facility: Acesion Pharma Investigational Site 210
city: Zalaegerszeg
country: Hungary
facility: Acesion Pharma Investigational Site 204
Study officials:
References: