Atrial fibrillation (AF) MedDRA version: 7.1 Level: PT Classification code 10003658
Conditions
Interventions
Product Code: AZD7009 (AR-H065522XX)
Pharmaceutical Form: Solution for infusion
Current Sponsor code: AZD7009 (AR-H065522XX)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 2.7
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy of iv AZD7009 in all treatment groups versus placebo, in conversion of AF. The primary outcome variable for the evaluation of this objective is: -the proportion of patients that have converted from AF within 90 min from start of infusion. Conversion has occurred if SR (and/or AV junctional rhythm) is maintained for at least 2 min A secondary outcome variable evaluating the primary objective is: -the time to conversion from AF from start of infusion up to 90 min ;Secondary Objective: A summary of the secondary objectives and variables of this study are: -To study the efficacy of AZD7009, versus placebo, in facilitating DC cardioversion from AF in patients -To study the efficacy of AZD7009, versus placebo in maintaining DC cardioverted patients in SR and the proportion of patients with immediate relapse of AF within 2 min after DC cardioversion (IRAF) -To study QT dynamics before and after conversion from AF -To study the importance of AF duration, demographic variables, atrial size, concomitant diseases and concurrent medication, with respect to success of conversion -To evaluate safety and tolerability of AZD7009 -To characterise the PK after iv administration of AZD7009 ;Primary end point(s): | — |
Countries
Denmark, Finland, Germany, Hungary, Sweden
Outcome results
None listed