Long-term safety in Atrial Fibrillation patients
Study identifier:D1250C00042
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Long-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
Medical condition
Persistent or Permanent Nonvalvular Atrial Fibrillation
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD0837, VKA INR 2-3
Sex
All
Actual Enrollment
523
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: 01 May 2009
Study Completion Date: 01 May 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Verification:
Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AZD0837 Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od |
| Active Comparator: 2 | Drug: VKA INR 2-3 Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5 Other Name: warfarin |
Contacts
Investigators
Principal Investigator
Lars Hvilstedt Rasmussen
Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark
