Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1084 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-06-30

Brief Summary

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The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.

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Detailed Description

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Conditions

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Nonvalvular Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Intervention Type DRUG

Tablet, PO for a period of 3-9 months.

Interventions

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AZD0837

ER tablet, PO, once daily for a period of 3-9 months.

Intervention Type DRUG

Vitamin-K antagonist at INR 2-3

Tablet, PO for a period of 3-9 months.

Intervention Type DRUG

AZD0837

ER tablet, PO, twice daily for a period of 3-9 months

Intervention Type DRUG

Other Intervention Names

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Warfarin

Eligibility Criteria

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Inclusion Criteria

* Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.
* Previous cerebral ischemic attack (stroke or TIA, \>30 days prior to randomization)
* Previous systemic embolism.
* Symptomatic congestive heart failure (CHF)
* Impaired left ventricular systolic function
* Diabetes mellitus
* Hypertension requiring anti-hypertensive treatment.

Exclusion Criteria

* AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
* Known contraindication to VKA treatment
* Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
* Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No