A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)

Atrial Fibrillation Clinical Trial

Official title:

A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study of AP30663 Given Intravenously for Cardioversion in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571385
• Other study ID #: AP30663-2001
• Secondary ID: 2018-004445-17
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2019
• Est. completion date: January 23, 2023

Study information

• Verified date: April 2023
• Source: Acesion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 23, 2023
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• AP30663
Administer by intravenous infusion.
• Placebo
Placebo matched to AP30663.

Locations

Country	Name	City	State
Denmark	Acesion Pharma Investigational Site 110	Aalborg
Denmark	Acesion Pharma Investigational Site 106	Copenhagen
Denmark	Acesion Pharma Investigational Site 108	Hellerup
Denmark	Acesion Pharma Investigational Site 113	Hillerød
Denmark	Acesion Pharma Investigational Site 105	Roskilde
Hungary	Acesion Pharma Investigational Site 202	Budapest
Hungary	Acesion Pharma Investigational Site 203	Budapest
Hungary	Acesion Pharma Investigational Site 207	Budapest
Hungary	Acesion Pharma Investigational Site 212	Budapest
Hungary	Acesion Pharma Investigational Site 213	Budapest
Hungary	Acesion Pharma Investigational Site 214	Budapest
Hungary	Acesion Pharma Investigational Site 211	Pecs
Hungary	Acesion Pharma Investigational Site 201	Szekszárd
Hungary	Acesion Pharma Investigational Site 210	Szentes
Hungary	Acesion Pharma Investigational Site 204	Zalaegerszeg

Sponsors (1)

Lead Sponsor	Collaborator
Acesion Pharma

Countries where clinical trial is conducted

Denmark,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants That Have Converted From AF and Subsequently Have no AF Recurrence Within 1 min of Conversion From AF		Within 90 Minutes From the Start of Infusion
Secondary	Time to Conversion From AF		From Start of Infusion up to Day 2
Secondary	Proportion of Participants With Immediate Relapse of AF (IRAF) After Pharmacological or Direct-current (DC) Cardioversion		Within 5 Minutes After Cardioversion
Secondary	Proportion of Participants in Sinus Rhythm (SR)		At 3-hour After Start of Infusion
Secondary	Proportion of Participants in SR		At 24-hour After Start of Infusion
Secondary	Proportion of Participants in SR		At Day 30 After Start of Infusion
Secondary	Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Day 30
Secondary	Changes in Fridericia's Correction of QT Interval (QTcF) Interval Data Over Time		Day 1 up to Day 2
Secondary	Volume of Distribution (Vd) of AP30663		Day 1 up to Day 2
Secondary	Clearance (CL) of AP30663		Day 1 up to Day 2
Secondary	Peak Plasma Concentration (Cmax) of AP30663		Day 1 up to Day 2
Secondary	Time to Reach Peak Plasma Concentration (Tmax) of AP30663		Day 1 up to Day 2
Secondary	Terminal Half Life of (T1/2) of AP30663		Day 1 up to Day 2