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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
First received
Last updated
Start date September 9, 2019
Est. completion date January 23, 2023

Study information

Verified date November 2023
Source Acesion Pharma
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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 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 Time to Conversion From Atrial Fibrillation From Start of Infusion The 12-lead Holter monitoring equipment was used to monitor heart rate and its rhythm. ECG was performed in a standardized manner after the participant had rested in the semi-supine position for at least 5 minutes. Time to conversion (in minutes) was calculated by time of conversion or censoring minus time of start of infusion. From start of infusion (Day 1) up to Day 2
Secondary Percentage of Participants With Relapse of AF Within 5 Minutes (IRAF) After Pharmacological or Direct Current (DC) Cardioversion The 12-lead Holter monitoring equipment was used to monitor heart rate and its rhythm. ECG was performed in a standardized manner after the participant had rested in the semi-supine position for at least 5 minutes. Participants with relapse of AF within 5 minutes following pharmacological or DC cardioversion was presented by treatment and analyzed using a logistic regression model. Percentages were based on "number of participants with relapse of AF within 5 minutes after Pharmacological or DC cardioversion" divided by "total number of participants" *100 in each treatment group. Within 5 minutes after cardioversion (Day 1)
Secondary Percentage of Participants With Sinus Rhythm (SR) at 3 Hours, 24 Hours and Day 30 After Start of Infusion The 12-lead Holter monitoring equipment was used to monitor heart rate and its rhythm. ECG was performed in a standardized manner that the participant had rested in the semi-supine position for at least 5 minutes. Percentage of participants in SR was assessed from Holter ECGs at 3 hours, 24 hours and Day 30 after start of infusion. Percentages were based on "number of participants in SR at 3 hours, 24 hours and Day 30 after start of infusion" divided by "total number of participants" *100 in each treatment group. At 3 hours, 24 hours and Day 30 after start of Infusion (Day 1)
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAEs are defined as any AE occurring or worsening on or after the first dose of study medication. A serious adverse event (SAE) is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. TEAEs include both serious and non-serious adverse events. From start of infusion (Day 1) up to follow-up (Day 35)
Secondary Changes From Baseline in Fridericia's Correction of QT Interval (?QTcF) Interval Data Over Time QTcF was assessed based on 12-lead Holter monitoring equipment. Triplicate ECGs were extracted at the same time points as PK sampling and were read in a semi-automated manner by a blinded cardiologist. The participant rested in the semi-supine position for at least 5 minutes at ECG extraction timepoints. Change from baseline was estimated based on a linear mixed-effects model: ?QTcF = Time + Treatment + Time*Treatment + Baseline QTcF. Baseline, 15 minutes, 45 minutes, 2 hours, 8 hours and 24 hours post-dose
Secondary Maximum Observed Peak Plasma Concentration (Cmax) of AP30663 Cmax was defined as the maximum observed peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Blood samples were collected at indicated timepoints. Pharmacokinetics (PK) was conducted using standard noncompartmental method. 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
Secondary Time to Reach Peak Plasma Concentration (Tmax) of AP30663 Tmax was directly determined from concentration time data. Blood samples were collected at indicated timepoints. Pharmacokinetics was conducted using standard noncompartmental method. 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
Secondary Terminal Half Life of (T1/2) of AP30663 T1/2 was calculated as loge (2) per elimination rate constant (kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were collected at indicated timepoints. Pharmacokinetics was conducted using standard noncompartmental method. 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
Secondary Area Under the Concentration Time Curve From Pre-dose Concentration up to 30 Minutes (AUC0-0.5) of AP30663 AUC0-0.5 was defined as area under the concentration time curve from pre-dose concentration up to 30 minutes. Blood samples were collected at indicated timepoints. Pharmacokinetics was conducted using standard noncompartmental method. Baseline (pre-infusion) and at 5, 15, 25, 30 minutes post-infusion
Secondary Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUC0-t) of AP30663 AUC0-t was defined as area under the concentration-time curve from time zero to time of last measurable concentration. Blood samples were collected at indicated timepoints. Pharmacokinetics was conducted using standard noncompartmental method. 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
Secondary Area Under the Concentration-Time Curve From Pre-dose (Zero) Through Concentration to Infinity (AUC0-inf) of AP30663 AUC0-inf was defined as area under the concentration time curve from pre-dose through concentration to infinity (extrapolated), calculated as AUC0-t + Ct/Kel, where Ct is the last observed non-zero concentration. Blood samples were collected at indicated timepoints. Pharmacokinetics was conducted using standard noncompartmental method. 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
Secondary Elimination Rate Constant (Kel) of AP30663 Kel represents the fraction of drug eliminated per unit of time. Elimination rate constant was calculated using linear regression on the terminal portion of the log-linear concentration versus time curve. Blood samples were collected at indicated timepoints. Pharmacokinetics was conducted using standard noncompartmental method. 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
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