A Controlled, Randomized, Parallel , Multi-centre Feasibility Study of the Oral Direct Thrombin Inhibitor, AZD0837, Given as ER Formulation, in the Prevention of Stroke and Systolic Embolic Events in Patients With Atrial Fibrillation, Who Are Appropriate for But Unable/Unwilling to Take VKA Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 128
- Locations
- 39
- Primary Endpoint
- Premature Discontinuation of Study or Study Drug Due to Any Reason
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Either one of the following risk factors is sufficient for inclusion (high risk patient)
- •Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), >30 days prior to randomization)
- •Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
- •Symptomatic congestive heart failure
- •Impaired left ventricular systolic function
- •Diabetes mellitus; Hypertension requiring anti-hypertensive treatment
- •In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy
Exclusion Criteria
- •Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
- •Conditions associated with increased risk of major bleeding
Outcomes
Primary Outcomes
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
The premature discontinuation of study or study drug due to any reason
Premature Discontinuation of Study Drug Due to Any Reason
Time Frame: 24 weeks (randomisation visit to last treatment visit)
The premature discontinuation of study drug due to any reason
Premature Discontinuation of Study Due to Any Reason
Time Frame: 28 weeks (randomisation visit to last follow up visit)
\|The premature discontinuation of study due to any reason
Compliance With Study Drug
Time Frame: 24 weeks (randomisation visit to last treatment visit) according to protocol
\[(number of doses dispensed-number of doses returned)/number of days between visits\]\*100
Compliance With Study Visits/Assessments
Time Frame: 28 weeks (randomisation visit to last follow up visit) according to protocol
(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
Secondary Outcomes
- Change in Creatinine Level(4 weeks according to protocol (randomisation visit to week 4 visit))
- Bilirubin(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))
- Bleeding Events(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)(4 weeks after baseline according to protocol)
- Plasma Concentration of AR-H067637XX (Active Metabolite)(4 weeks after baseline according to protocol)
- Alanine Aminotransferase (ALAT)(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))
- Change in D-Dimer Level(4 weeks according to protocol.(baseline to week 4 visit))
- Activated Partial Thromboplastin Time (APTT)(4 weeks according to protocol.(baseline to week 4 visit))
- Ecarin Clotting Time (ECT)(4 weeks according to protocol.(baseline to week 4 visit))