Status:
COMPLETED
Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)
Lead Sponsor:
AstraZeneca
Conditions:
Persistent or Permanent Non-valvular Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00623779
Start Date
October 1 2007
End Date
October 1 2008
Last Update
March 23 2012
Active Locations (38)
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1
Research Site
Aalborg, Denmark
2
Research Site
Arhus N, Denmark
3
Research Site
Copenhagen, Denmark
4
Research Site
Esbjerg, Denmark