Official Title: “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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: AZD0837
  • ER formulation
• Drug: Aspirin
  • Oral form

Primary Measures

• Assess feasibility of conducting a study in patients with atrial fibrillation, who are appropriate for but unable or unwilling to take Vitamin-K antagonist(VKA) therapy, by evaluation of drop-out rate and compliance with treatment and study procedures
  • Safety Issue?: No

Secondary Measures

• to provide information on recruitment rate, safety and tolerability in this patient population; to provide dose-guiding information PK/PD)
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Gregory Y Lip, MD Principal Investigator Birmingham City Hospital  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00623779

Study ID Number: D1250C00051

ClinicalTrials.gov Identifier: NCT00623779

Health Authority: Denmark: Danish Medicines Agency