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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Nonvalvular Atrial Fibrillation

Treatments: Drug: AZD0837; Drug: Vitamin-K antagonist at INR 2-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00684307

D1250C00008

Details and patient eligibility

About

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.

Enrollment: 1,084 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,084 participants in 5 patient groups

1

Experimental group

Description:

AZD0837 450 mg

Treatment:

Drug: AZD0837

Drug: AZD0837

2

Experimental group

Description:

AZD0837 200 mg

Treatment:

Drug: AZD0837

Drug: AZD0837

3

Experimental group

Description:

AZD0837 300 mg

Treatment:

Drug: AZD0837

Drug: AZD0837

4

Experimental group

Description:

AZD0837 150 mg

Treatment:

Drug: AZD0837

Drug: AZD0837

5

Active Comparator group

Description:

Vitamin-K antagonist at INR 2-3

Treatment:

Drug: Vitamin-K antagonist at INR 2-3