ong-term treatment with the oral direct thrombin inhibitor AZD0837, compared to Vitamin-K antagonists, as stroke prevention in patients with non-valvular atrial fibrillation and one or more risk factors for stroke and systemic embolic events. A 5-year follow-up study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

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

Aged <18 years at inclusion

Weight <40 kg at enrolment

Childbearing potential, ie women must be either post-menopausal a, permanently sterilized or, if of childbearing potential, must have a negative pregnancy test prior to initiation of study drug and use a reliable form of contraception b before and during the participation in the study. Women must not be breast feeding
aPost menopausal patients are defined as patients with natural or induced menopause with last menstruation >1 year ago or bilateral oophorectomy
bReliable 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 <30 ml/min) at the time of enrolment

Known hepatic disease and/or ALAT >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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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