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

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.

Intervention(s) in this Clinical Trial

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

Primary Measures

• Premature Discontinuation of Study or Study Drug Due to Any Reason
  • Time Frame: 28 week (randomisation visit to last follow up visit in study) according to protocols
    Safety Issue?: No
• Premature Discontinuation of Study Drug Due to Any Reason
  • Time Frame: 24 weeks (randomisation visit to last treatment visit)
    Safety Issue?: No
• Premature Discontinuation of Study Due to Any Reason
  • Time Frame: 28 weeks (randomisation visit to last follow up visit)
    Safety Issue?: No
• Compliance With Study Drug
  • Time Frame: 24 weeks (randomisation visit to last treatment visit) according to protocol
    Safety Issue?: No
• Compliance With Study Visits/Assessments
  • Time Frame: 28 weeks (randomisation visit to last follow up visit) according to protocol
    Safety Issue?: No

Secondary Measures

• Bleeding Events
  • Time Frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
    Safety Issue?: Yes
• Change in Creatinine Level
  • Time Frame: 4 weeks according to protocol (randomisation visit to week 4 visit)
    Safety Issue?: Yes
• Alanine Aminotransferase (ALAT)
  • Time Frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
    Safety Issue?: Yes
• Bilirubin
  • Time Frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
    Safety Issue?: Yes
• Plasma Concentration of AZD0837 (Prodrug)
  • Time Frame: 4 weeks after baseline according to protocol
    Safety Issue?: Yes
• Plasma Concentration of AR-H067637XX (Active Metabolite)
  • Time Frame: 4 weeks after baseline according to protocol
    Safety Issue?: Yes
• Change in D-Dimer Level
  • Time Frame: 4 weeks according to protocol.(baseline to week 4 visit)
    Safety Issue?: Yes
• Activated Partial Thromboplastin Time (APTT)
  • Time Frame: 4 weeks according to protocol.(baseline to week 4 visit)
    Safety Issue?: Yes
• Ecarin Clotting Time (ECT)
  • Time Frame: 4 weeks according to protocol.(baseline to week 4 visit)
    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 Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Gregory Y Lip, MD Principal Investigator Birmingham City Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

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