Paroxysmal persistent or permanent non-valvular atrial fibrillation MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of informed consent Patients who fulfilled the inclusion criteria in study D1250C00008 and completed the planned study treatment period in study D1250C00008 without safety concerns regarding continued treatment, as assessed by the investigator 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: Aged 1 year ago or bilateral oophorectomy b Reliable form of contraception is defined as: oral contraceptive, implant, long term injectable contraceptive, intrauterine device or tubal ligation. However, female patients using hormonal anti-conception method (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional barrier method for contraception (condom or diaphragm) AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism Known contraindication to VKA treatment Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment Myocardial infarction, heart surgery (eg coronary artery bypass graft, CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the previous three months prior to inclusion Stroke and/or systemic embolism within the previous 30 days prior to inclusion Conditions associated with increased risk of major bleeding for example: - history of intracranial bleeding - history of bleeding gastrointestinal disorder and/or endoscopically verified ulcer disease within the last year prior to inclusion - major surgical procedure or trauma two weeks prior to inclusion Diastolic blood pressure (DBP) >100 mmHg or systolic blood pressure (SBP) >180 mmHg with or without antihypertensive treatment Renal impairment (calculated creatinine clearance 3xULN at enrolment History or presence of Human Immunodeficiency Virus (HIV) or infectious hepatitis including known HbSAg positive or antibodies against Hepatitis C Known Gilberts syndrome Anaemia (Hb<100 g/L = 6.2 mmol/L) Platelet count <100 x 109/L Treatment with antiplatelet other than ASA =100 mg/day or fibrinolytic agents within 10 days before inclusion Planned (at the time of enrolment) cardioversion or surgery during the study Other serious disease that give a calculated survival less than 12 months or any condition making a patient too frail to participate in the study Known drug addiction and/or alcohol abuse Inability to complete the study according to the protocol Previous enrolment or inclusion of treatment in the present study. Participating in any other clinical study, except study D1250C00008, within 4 weeks (in UK within 12 weeks) prior to enrolment Treatment with AZD0837 in previous or ongoing AZD0837 study, except study D1250C00008 Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety and tolerability of long-term treatment with AZD0837 compared to Vitamin-K antagonist (VKA) in non-valvular atrial fibrillation patients (AF) with a moderate to high risk of stroke and systemic embolic events. ;Secondary Objective: To evaluate the pharmacokinetics of AZD0837 and its metabolites with special regard to the variability. To evaluate the effect of AZD0837 on d-dimer levels compared to VKA in AF patients with a moderate to high risk of stroke and systemic embolic events. To evaluate the effect of AZD0837 on Activated Partial Thromboplastin Time (APTT) and Ecarin coagulation time (ECT) in patients with AF and a moderate to high risk of stroke and systemic embolic events. Exploratory: To explore anticoagulation-related quality of life and satisfaction among patients given AZD0837 compared to patients given VKA agents using the Duke Anticoagulation Satisfaction Scale (DASS). To explore general treatment satisfaction with AZD0837 compared to VKA agents using the Treatment Satisfaction Questionnaire for Medication (TSQM) including effectiveness, side effects, convenience and global satisfaction ;Primary end point(s): Primary outcome variables: - Safety AE (including bleedings) laboratory safety values physical examination electrocardiogram (ECG) vital signs (Blood pressure (BP) and pulse) | — |
Countries
Austria, Denmark, Hungary, Sweden
Outcome results
None listed