Back to resultsLong-term Safety in Atrial Fibrillation Patients
Primary Purpose
Persistent or Permanent Nonvalvular Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AZD0837
VKA INR 2-3
Sponsored by
About this trial
This is an interventional prevention trial for Persistent or Permanent Nonvalvular Atrial Fibrillation
Eligibility Criteria
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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
Participants
Secondary Outcome Measures
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline
ULN=Upper limit of Normal
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline
Creatinine: Absolute Change From Baseline, at End of Treatment
D-dimer:Median and Quartile Range at End of Treatment
Median (Lower Quartile-Upper Quartile ), ng/mL
Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment
Median Full range, Seconds
Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment
AZD0837: Plasma Concentration of AZD0837 at End of Treatment
AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00645853
Brief Title
Long-term Safety in Atrial Fibrillation Patients
Official Title
Long-term Treatment With the Oral Direct Thrombin Inhibitor AZD0837, Compared to Vitamin-K Antagonists, as Stroke Prevention in Patients With Non-valvular Atrial Fibrillation and One or More Risk Factors for Stroke and Systemic Embolic Events. A 5-year Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent or Permanent Nonvalvular Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
523 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AZD0837
Intervention Description
Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
Intervention Type
Drug
Intervention Name(s)
VKA INR 2-3
Other Intervention Name(s)
warfarin
Intervention Description
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
Primary Outcome Measure Information:
Title
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
Description
Participants
Time Frame
154-711 days on treatment
Secondary Outcome Measure Information:
Title
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline
Description
ULN=Upper limit of Normal
Time Frame
From baseline to Follow up
Title
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline
Time Frame
From baseline to Follow up
Title
Creatinine: Absolute Change From Baseline, at End of Treatment
Time Frame
Baseline and End of treatment
Title
D-dimer:Median and Quartile Range at End of Treatment
Description
Median (Lower Quartile-Upper Quartile ), ng/mL
Time Frame
End of treatment
Title
Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment
Description
Median Full range, Seconds
Time Frame
Baseline and End of treatment
Title
Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment
Time Frame
Baseline and End of Treatment
Title
AZD0837: Plasma Concentration of AZD0837 at End of Treatment
Time Frame
End of treatment
Title
AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment
Time Frame
154-711 days on treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Hvilstedt Rasmussen, MD, PhD, FESC
Organizational Affiliation
Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Long-term Safety in Atrial Fibrillation Patients
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