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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
523
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
Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
Participants
Time frame: 154-711 days on treatment
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline
ULN=Upper limit of Normal
Time frame: From baseline to Follow up
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline
Time frame: From baseline to Follow up
Creatinine: Absolute Change From Baseline, at End of Treatment
Time frame: Baseline and End of treatment
D-dimer:Median and Quartile Range at End of Treatment
Median (Lower Quartile-Upper Quartile ), ng/mL
Time frame: End of treatment
Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment
Median Full range, Seconds
Time frame: Baseline and End of treatment
Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment
Time frame: Baseline and End of Treatment
AZD0837: Plasma Concentration of AZD0837 at End of Treatment
Time frame: End of treatment
AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment
Time frame: 154-711 days on treatment
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