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”

The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).

Study Type: Interventional

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

Study Primary Completion Date: March 2013

Intervention(s) in this Clinical Trial

• Drug: AZD0837
• Drug: Vitamin-K Antagonists (warfarin)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• To evaluate safety and tolerability of long-term treatment with AZD0837 compared to Vitamin-K Antagonist (VKA) in Atrial Fibrillation patients with a moderate to high risk of stroke and systemic embolic events.
  • Safety Issue?: Yes

Secondary Measures

• To evaluate the PK of AZD0837 and metabolites; To evaluate the effect of AZD0837 on PD markers and coagulation assays in Atrial Fibrillation patients with a moderate to high risk of stroke and systemic embolic events.
  • Safety Issue?: No

Inclusion Criteria:

• Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
• completing treatment with study drug in D1250C00008.

Exclusion Criteria:

• Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
• Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than
• Atrial Fibrillation requiring chronic anticoagulation treatment
• Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
• 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

Lars Hvilstedt Rasmussen, MD, PhD, FESC Principal Investigator Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645853

Study ID Number: D1250C00042

ClinicalTrials.gov Identifier: NCT00645853

Health Authority: Denmark: Danish Medicines Agency