A double-blind, randomised, placebo-controlled, parallel-group, multicentre, phase II study to assess the efficacy of AZD7009 (AR-H065522XX) given intravenously (infusion for 15 or 30 minutes) to patients for conversion of atrial fibrillatio

• Conditions: Atrial fibrillation (AF); MedDRA version: 7.1Level: PTClassification code 10003658

• Registration Number: EUCTR2005-000204-13-DK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1.Provision of informed consent.
2.Clinical indication for cardioversion of AF.
3.Current episode of AF lasting between 48 h and 90 days, before day of
randomisation.
4.Patients with no prior cardioversion or patients with 1 or 2 successful cardioversion(s) of AF/Atrial Flutter(AFl) during the last 12 months. Each successful cardioversion must be followed by at least 3 months in SR.
5.Effective oral anticoagulation according to local routines or a TEE without any
finding of intracardial thrombus or signs of thrombogenecity.
6.Age from 18 up to 80 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Prior unsuccessful cardioversion of AF/AFl.
2.Women of childbearing potential (only postmenopausal or surgically sterilised
women may be included).
3.Ongoing atrial flutter.
4.Myocardial infarction, unstable angina pectoris or other signs of myocardial
ischaemia or cardiac surgery/percutaneous coronary intervention (PCI) in the last
6 weeks before day of randomisation or planned PCI/cardiac surgery.
5.Haemodynamically unstable condition as judged by the investigator.
6.NYHA class 3 or 4.
7.Left ventricular ejection fraction <35 % (echocardiographic) or known moderately
or severely depressed systolic function (qualitative echocardiographic
measurement).
8.Clinically significant sinus and/or AV node dysfunction.
9.Bradycardia <40 beats per minutes (bpm), measured as the mean heart rate
during 30 seconds.
10.Hypotension (systolic BP <90 mm Hg).
11.Any clinically significant valvular heart disease.
12.Known hypertrophic cardiomyopathy/significant left ventricular hypertrophy (free
wall or septal thickness >13 mm).
13.QTc (Bazett) >450 ms (when measured during AF, the mean heart rate should
preferably be 50-100 bpm. The QTcB should be calculated at AF as the mean of
at least 5 consecutive RR intervals with consecutive QT intervals).
14.Any QRS duration >150 ms.
15.Bifascicular blocks: complete left bundle branch block (LBBB) or complete right
bundle branch block (RBBB) in combination with left anterior hemiblock (LAH) or
left posterior hemiblock (LPH).
16.Known history of Torsade de Pointes (TdP).
17.Known family history of long QT syndrome, Brugada syndrome or unexplained
sudden death below the age of 45 years.
18.Pacemaker.
19.Known preexcitation with (WPW syndrome) or without arrhythmias.
20.Concomitant medication with drug(s) prolonging the action potential duration
21.Serum or plasma potassium <3.8 mmol/L or >5.0 mmol/L.
22.Untreated hyperthyroidism/untreated hypothyroidism.
23.Haemoglobin <100 g/L.
24.Clinically important hepatic and/or renal dysfunction as judged by the investigator.
25.Any condition which in the opinion of the investigator would render the patient
unsuitable for inclusion in the study.
26.Participation in another intervention trial during the last 30 days before
enrolment, or previously enrolled or randomised in the present study.
27.Involvement in the planning and conduct of the study (applies to both
AstraZeneca staff or staff at the investigational site).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified