Overview

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

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Aspirin
Criteria
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