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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AP30663
Placebo
Sponsored by
Acesion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acesion Pharma Investigational Site 110
  • Acesion Pharma Investigational Site 106
  • Acesion Pharma Investigational Site 108
  • Acesion Pharma Investigational Site 113
  • Acesion Pharma Investigational Site 105
  • Acesion Pharma Investigational Site 202
  • Acesion Pharma Investigational Site 203
  • Acesion Pharma Investigational Site 207
  • Acesion Pharma Investigational Site 212
  • Acesion Pharma Investigational Site 213
  • Acesion Pharma Investigational Site 214
  • Acesion Pharma Investigational Site 211
  • Acesion Pharma Investigational Site 201
  • Acesion Pharma Investigational Site 210
  • Acesion Pharma Investigational Site 204

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1: AP30663

Part 1: Placebo

Part 2: AP30663

Part 2: Placebo

Arm Description

Participants will receive single dose of AP30663.

Participants will receive placebo matched to AP30663.

Participants will receive a single dose of one of the multiple dose levels of AP30663.

Participants will receive placebo matched to AP30663.

Outcomes

Primary Outcome Measures

Proportion of Participants That Have Converted From AF and Subsequently Have no AF Recurrence Within 1 min of Conversion From AF

Secondary Outcome Measures

Time to Conversion From AF
Proportion of Participants With Immediate Relapse of AF (IRAF) After Pharmacological or Direct-current (DC) Cardioversion
Proportion of Participants in Sinus Rhythm (SR)
Proportion of Participants in SR
Proportion of Participants in SR
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Changes in Fridericia's Correction of QT Interval (QTcF) Interval Data Over Time
Volume of Distribution (Vd) of AP30663
Clearance (CL) of AP30663
Peak Plasma Concentration (Cmax) of AP30663
Time to Reach Peak Plasma Concentration (Tmax) of AP30663
Terminal Half Life of (T1/2) of AP30663

Full Information

First Posted
September 25, 2020
Last Updated
April 25, 2023
Sponsor
Acesion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04571385
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
December 13, 2022 (Actual)
Study Completion Date
January 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acesion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: AP30663
Arm Type
Experimental
Arm Description
Participants will receive single dose of AP30663.
Arm Title
Part 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to AP30663.
Arm Title
Part 2: AP30663
Arm Type
Experimental
Arm Description
Participants will receive a single dose of one of the multiple dose levels of AP30663.
Arm Title
Part 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to AP30663.
Intervention Type
Drug
Intervention Name(s)
AP30663
Intervention Description
Administer by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to AP30663.
Primary Outcome Measure Information:
Title
Proportion of Participants That Have Converted From AF and Subsequently Have no AF Recurrence Within 1 min of Conversion From AF
Time Frame
Within 90 Minutes From the Start of Infusion
Secondary Outcome Measure Information:
Title
Time to Conversion From AF
Time Frame
From Start of Infusion up to Day 2
Title
Proportion of Participants With Immediate Relapse of AF (IRAF) After Pharmacological or Direct-current (DC) Cardioversion
Time Frame
Within 5 Minutes After Cardioversion
Title
Proportion of Participants in Sinus Rhythm (SR)
Time Frame
At 3-hour After Start of Infusion
Title
Proportion of Participants in SR
Time Frame
At 24-hour After Start of Infusion
Title
Proportion of Participants in SR
Time Frame
At Day 30 After Start of Infusion
Title
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Day 1 up to Day 30
Title
Changes in Fridericia's Correction of QT Interval (QTcF) Interval Data Over Time
Time Frame
Day 1 up to Day 2
Title
Volume of Distribution (Vd) of AP30663
Time Frame
Day 1 up to Day 2
Title
Clearance (CL) of AP30663
Time Frame
Day 1 up to Day 2
Title
Peak Plasma Concentration (Cmax) of AP30663
Time Frame
Day 1 up to Day 2
Title
Time to Reach Peak Plasma Concentration (Tmax) of AP30663
Time Frame
Day 1 up to Day 2
Title
Terminal Half Life of (T1/2) of AP30663
Time Frame
Day 1 up to Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Acesion Pharma Investigational Site 110
City
Aalborg
Country
Denmark
Facility Name
Acesion Pharma Investigational Site 106
City
Copenhagen
Country
Denmark
Facility Name
Acesion Pharma Investigational Site 108
City
Hellerup
Country
Denmark
Facility Name
Acesion Pharma Investigational Site 113
City
Hillerød
Country
Denmark
Facility Name
Acesion Pharma Investigational Site 105
City
Roskilde
Country
Denmark
Facility Name
Acesion Pharma Investigational Site 202
City
Budapest
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 203
City
Budapest
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 207
City
Budapest
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 212
City
Budapest
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 213
City
Budapest
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 214
City
Budapest
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 211
City
Pecs
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 201
City
Szekszárd
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 210
City
Szentes
Country
Hungary
Facility Name
Acesion Pharma Investigational Site 204
City
Zalaegerszeg
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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