Clinical trial NCT00915356: Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Official title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Dose-escalating Study of AZD1305 Given Intravenously for Cardioversion of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: AZD1305
intravenous cardioversion of Atrial Fibrillation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 228
Sex: ALL
Minimum age (years): 20
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 is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.


Eligibility criteria: Inclusion Criteria:

* Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm
* Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation
* Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines

Exclusion Criteria:

* Potassium level below 3.8 mmol/L measured in serum or plasma
* QTcF interval \>440 ms

Primary outcomes:
measure: Dose-response Relationship for QTcF Interval of AZD1305
timeFrame: At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).
measure: Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)
timeFrame: Within 90 minutes from start of infusion
Secondary outcomes:
measure: Wide QRS Tachycardias
timeFrame: From start of study drug infusion until discharge from hospital on study day 2.
measure: Heart Rhythm. Number of Participants With Early Relapse Into AF.
timeFrame: Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR
measure: Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion
timeFrame: During 24 hours following start of study drug infusion
measure: Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.
timeFrame: During 13 to 18 days following study drug infusion
measure: Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.
timeFrame: Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.
measure: Maximal Observed Plasma Concentration of AZD1305
timeFrame: Up to 24 hours following start of study drug infusion
measure: Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days
timeFrame: Conversion from AF to SR within 90 minutes from start of infusion
measure: Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.
timeFrame: Conversion from AF to SR within 90 minutes from start of infusion
measure: Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months
timeFrame: Conversion from AF to SR within 90 minutes from start of infusion
measure: Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion
timeFrame: Six hours following start of study drug infusion
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Research Site
state: CZ
city: Praha 2
country: Czech Republic
facility: Research Site
city: Znojmo
country: Czech Republic
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Deventer
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Sneek
country: Netherlands
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: RUD
country: Norway
facility: Research Site
city: Tromso
country: Norway
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Lubin
country: Poland
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Ruzomberok
country: Slovakia
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: AZD1305 Medical Science Director
role: STUDY_DIRECTOR
affiliation: Péterfy HospitalDepartment of Cardiology1076 Budapest, Péterfi Sándor str. 8-20HUNGARY
name: Aladár Rónaszéki
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ronaszeki A, Alings M, Egstrup K, Gaciong Z, Hranai M, Kiraly C, Sereg M, Figatowski W, Bondarov P, Johansson S, Frison L, Edvardsson N, Berggren A. Pharmacological cardioversion of atrial fibrillation--a double-blind, randomized, placebo-controlled, multicentre, dose-escalation study of AZD1305 given intravenously. Europace. 2011 Aug;13(8):1148-56. doi: 10.1093/europace/eur120. Epub 2011 May 11.