The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
128
Premature Discontinuation of Study or Study Drug Due to Any Reason
The premature discontinuation of study or study drug due to any reason
Time frame: 28 week (randomisation visit to last follow up visit in study) according to protocols
Premature Discontinuation of Study Drug Due to Any Reason
The premature discontinuation of study drug due to any reason
Time frame: 24 weeks (randomisation visit to last treatment visit)
Premature Discontinuation of Study Due to Any Reason
\|The premature discontinuation of study due to any reason
Time frame: 28 weeks (randomisation visit to last follow up visit)
Compliance With Study Drug
\[(number of doses dispensed-number of doses returned)/number of days between visits\]\*100
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol
Compliance With Study Visits/Assessments
(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)\*100
Time frame: 28 weeks (randomisation visit to last follow up visit) according to protocol
Bleeding Events
Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
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Research Site
Aalborg, Denmark
Research Site
Arhus N, Denmark
Research Site
Copenhagen, Denmark
Research Site
Esbjerg, Denmark
Research Site
Frederikssund, Denmark
Research Site
Horsens, Denmark
Research Site
Silkeborg, Denmark
Research Site
Svendborg, Denmark
Research Site
Elverum, Norway
Research Site
Gjettum, Norway
...and 28 more locations
Change in Creatinine Level
Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time frame: 4 weeks according to protocol (randomisation visit to week 4 visit)
Alanine Aminotransferase (ALAT)
Number of patients while on study drug with Alanine aminotransferase (ALAT)\>=3 times upper limit of normal.
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Bilirubin
Number of patients while on study drug with Bilirubin\>=2 times upper limit of normal.
Time frame: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)
Plasma Concentration of AZD0837 (Prodrug)
Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
Time frame: 4 weeks after baseline according to protocol
Plasma Concentration of AR-H067637XX (Active Metabolite)
Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
Time frame: 4 weeks after baseline according to protocol
Change in D-Dimer Level
Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time frame: 4 weeks according to protocol.(baseline to week 4 visit)
Activated Partial Thromboplastin Time (APTT)
Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time frame: 4 weeks according to protocol.(baseline to week 4 visit)
Ecarin Clotting Time (ECT)
Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Time frame: 4 weeks according to protocol.(baseline to week 4 visit)