Long-term Safety in Atrial Fibrillation Patients

Phase 2

Completed

• Conditions: Persistent or Permanent Nonvalvular Atrial Fibrillation
• Interventions: Drug: AZD0837; Drug: VKA INR 2-3

• Registration Number: NCT00645853
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-28
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2011-06-30
• Results First Submitted QC: 2012-02-02
• Status Verified: 2012-03
• Results First Posted: 2012-03-06
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 523

Inclusion Criteria

• Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
• completing treatment with study drug in D1250C00008.

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Exclusion Criteria

• Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
• Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment
• Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
• Conditions associated with increased risk of major bleeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD0837	-
2	VKA INR 2-3	-

Primary Outcome Measures

Name	Time	Method
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period	154-711 days on treatment	Participants

Secondary Outcome Measures

Name	Time	Method
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline	From baseline to Follow up	ULN=Upper limit of Normal
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline	From baseline to Follow up
Creatinine: Absolute Change From Baseline, at End of Treatment	Baseline and End of treatment
D-dimer:Median and Quartile Range at End of Treatment	End of treatment	Median (Lower Quartile-Upper Quartile ), ng/mL
Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment	Baseline and End of treatment	Median Full range, Seconds
Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment	Baseline and End of Treatment
AZD0837: Plasma Concentration of AZD0837 at End of Treatment	End of treatment
AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment	154-711 days on treatment