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-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-22
• 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 at randomisation. In patients with documented persistent AF, ie, they have previously undergone cardioversion for persistent (not paroxysmal) AF, the current episode could be between 8 h and 90 days at randomisation.
4.Effective oral anticoagulation with International Normalized Ratio (INR) >2 for 3 consecutive weeks at randomisation (if there are more stringent country specific guidelines, these can be utilised), or a TEE without any finding of intracardial thrombus or signs of thrombogenecity.
5.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.Cardioversion of AF/AFl within 4 weeks at randomisation, or unsuccessful cardioversion of current AF episode
2.Women of childbearing potential (only postmenopausal or surgically sterilised
women may be included).
3.Ongoing type I (counter-clockwise or clockwise) AFl.
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 congestive heartfailure.
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 <50 beats per minutes (bpm) during AF, 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.History of Torsade de Pointes or any other polymorphic ventricular tachycardia. History of sustained monomorphic ventricular tachycardia.
17.History of unexplained syncope, long QT syndrome or Brugada syndrome. Family history of long QT syndrome or unexplained sudden death below the age of 45 years.
18.Pacemaker or implantable cardioverter-defibrillator.
19.Known preexcitation with (WPW syndrome) or without arrhythmias.
20.Concomitant medication with drug(s) prolonging the action potential duration
21.Serum potassium <3.8 mmol/L or >5.0 mmol/L or plasma potassium <3.6mmol/L or >5.0 mmol/L..
22.Untreated hyperthyroidism/untreated hypothyroidism.
23.Haemoglobin <100 g/L.
24. Clinically important hepatic dysfunction (ASAT, ALAT >3xULN(Upper Limit of Normal)) and/or renal dysfunction (calculated creatinine clearance <30 mL/min).
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