Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

NCT00915356 | Completed Phase 2 Results DMC

• 2 other identifiers: D3191C000092009-009862-15 (EudraCT No)
• Study Type: interventional
• Target: 228
• Locations: 8 countries
• Sites: 31

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.

Conditions

Atrial Fibrillation

Keywords

AZD1305; intravenous cardioversion of Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Dose-response Relationship for QTcF Interval of AZD1305

  QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date \& time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed

  At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).

• Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)

  Conversion of AF to SR with maintenance of SR maintained for at least 1 minute

  Within 90 minutes from start of infusion

Secondary Outcomes (10)

• Wide QRS Tachycardias

  From start of study drug infusion until discharge from hospital on study day 2.

• Heart Rhythm. Number of Participants With Early Relapse Into AF.

  Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR

• Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion

  During 24 hours following start of study drug infusion

• Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.

  During 13 to 18 days following study drug infusion

• Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.

  Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.

Study Arms (2)

1

EXPERIMENTAL

AZD1305 iv infusion

Drug: AZD1305

2

PLACEBO COMPARATOR

Placebo iv infusion

Drug: Placebo

Interventions

AZD1305 DRUG

Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

1

Placebo DRUG

iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes

2

Eligibility Criteria

• Age: 20 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 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (31)

Research Site

Brno, CZ, Czechia

Location

Research Site

Prague, Czechia

Location

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Znojmo, Czechia

Location

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Aalborg, Denmark

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Esbjerg, Denmark

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Svendborg, Denmark

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Budapest, Hungary

Location

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Cegléd, Hungary

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Debrecen, Hungary

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Kecskemét, Hungary

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Székesfehérvár, Hungary

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Breda, Netherlands

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Deventer, Netherlands

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Leeuwarden, Netherlands

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Sneek, Netherlands

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Hamar, Norway

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Oslo, Norway

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Rud, Norway

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Tromsø, Norway

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Bytom, Poland

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Lubin, Poland

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Płock, Poland

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Ruda Śląska, Poland

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Torun, Poland

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Warsaw, Poland

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Martin, Slovakia

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Nitra, Slovakia

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Ružomberok, Slovakia

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Linköping, Sweden

Location

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Örebro, Sweden

Location

Research Site

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 21561900 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

clinicalTrialTransparency@astrazeneca.com

Study Officials

• AZD1305 Medical Science Director

  AstraZeneca R&D, Mölndal, Sweden

  STUDY DIRECTOR

• Aladár Rónaszéki

  Péterfy HospitalDepartment of Cardiology1076 Budapest, Péterfi Sándor str. 8-20HUNGARY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 1, 2012
• Results First Posted: February 1, 2012

Record last verified: 2012-01

Locations

SL (3); PL (6); SE (3); DK (3); NL (4); NO (4); CZ (3); HU (5)