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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Persistent or Permanent Non-valvular Atrial Fibrillation

Treatments: Drug: Aspirin; Drug: AZD0837

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623779

D1250C00051

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)