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

NCT04571385 | Completed Phase 2 Results

• 2 other identifiers: AP30663-20012018-004445-17
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 15

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

  The 12-lead Holter monitoring equipment was used to monitor heart rate and its rhythm. Electrocardiogram (ECG) was performed in a standardized manner after the participant had rested in the semi-supine position for at least 5 minutes. Conversion from AF to normal sinus rhythm within 90 minutes from start of infusion was determined by the investigator and documented with a rhythm strip confirming conversion. Percentages were based on "number of participants converted from atrial fibrillation and absence of recurrence of AF within 1 minute of conversion" divided by "total number of participants" \*100 in each treatment group. Analysis was performed based on Bayesian model.

  Within 90 minutes from the start of infusion (Day 1)

Secondary Outcomes (12)

• Time to Conversion From Atrial Fibrillation From Start of Infusion

  From start of infusion (Day 1) up to Day 2

• Percentage of Participants With Relapse of AF Within 5 Minutes (IRAF) After Pharmacological or Direct Current (DC) Cardioversion

  Within 5 minutes after cardioversion (Day 1)

• Percentage of Participants With Sinus Rhythm (SR) at 3 Hours, 24 Hours and Day 30 After Start of Infusion

  At 3 hours, 24 hours and Day 30 after start of Infusion (Day 1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

  From start of infusion (Day 1) up to follow-up (Day 35)

• Changes From Baseline in Fridericia's Correction of QT Interval (ΔQTcF) Interval Data Over Time

  Baseline, 15 minutes, 45 minutes, 2 hours, 8 hours and 24 hours post-dose

Study Arms (4)

Part 1: AP30663

EXPERIMENTAL

Participants will receive single dose of AP30663.

Drug: AP30663

Part 1: Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to AP30663.

Drug: Placebo

Part 2: AP30663

EXPERIMENTAL

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

Drug: AP30663

Part 2: Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to AP30663.

Drug: Placebo

Interventions

AP30663 DRUG

Administer by intravenous infusion.

Part 1: AP30663; Part 2: AP30663

Placebo DRUG

Placebo matched to AP30663.

Part 1: Placebo; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acesion Pharma: lead

Study Sites (15)

Acesion Pharma Investigational Site 110

Aalborg, Denmark

Location

Acesion Pharma Investigational Site 106

Copenhagen, Denmark

Location

Acesion Pharma Investigational Site 108

Hellerup, Denmark

Location

Acesion Pharma Investigational Site 113

Hillerød, Denmark

Location

Acesion Pharma Investigational Site 105

Roskilde, Denmark

Location

Acesion Pharma Investigational Site 202

Budapest, Hungary

Location

Acesion Pharma Investigational Site 203

Budapest, Hungary

Location

Acesion Pharma Investigational Site 207

Budapest, Hungary

Location

Acesion Pharma Investigational Site 212

Budapest, Hungary

Location

Acesion Pharma Investigational Site 213

Budapest, Hungary

Location

Acesion Pharma Investigational Site 214

Budapest, Hungary

Location

Acesion Pharma Investigational Site 211

Pécs, Hungary

Location

Acesion Pharma Investigational Site 201

Szekszárd, Hungary

Location

Acesion Pharma Investigational Site 210

Szentes, Hungary

Location

Acesion Pharma Investigational Site 204

Zalaegerszeg, Hungary

Location

Related Publications (1)

• Holst AG, Tomcsanyi J, Vestbjerg B, Grunnet M, Sorensen US, Diness JG, Bentzen BH, Edvardsson N, Hohnloser SH, Bhatt DL, Dorian P. Inhibition of the KCa2 potassium channel in atrial fibrillation: a randomized phase 2 trial. Nat Med. 2024 Jan;30(1):106-111. doi: 10.1038/s41591-023-02679-9. Epub 2023 Dec 13.

  PMID: 38092897 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Birgitte Vestbjerg
• Organization: Acesion Pharma

bve@acesionpharma.com

+45 20772575

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: September 9, 2019
• Primary Completion: December 13, 2022
• Study Completion: January 23, 2023
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (10); DK (5)