Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)

A Controlled, Randomized, Parallel , Multi-centre Feasibility Study of the Oral Direct Thrombin Inhibitor, AZD0837, Given as ER Formulation, in the Prevention of Stroke and Systolic Embolic Events in Patients With Atrial Fibrillation, Who Are Appropriate for But Unable/Unwilling to Take VKA Therapy

The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.

Inclusion Criteria:

• Either one of the following risk factors is sufficient for inclusion (high risk patient)
• Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30 days prior to randomization)
• Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
• Symptomatic congestive heart failure
• Impaired left ventricular systolic function
• Diabetes mellitus; Hypertension requiring anti-hypertensive treatment
• In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy

Exclusion Criteria:

• Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
• Conditions associated with increased risk of major bleeding