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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Persistent or Permanent Non-valvular Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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AZD0837

ER formulation

Intervention Type DRUG

Aspirin

Oral form

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No