Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)
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
1 other identifier
interventional
128
6 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 28, 2011
CompletedMarch 23, 2012
March 1, 2012
1 year
February 15, 2008
June 30, 2011
March 20, 2012
Conditions
Outcome Measures
Primary Outcomes (5)
Premature Discontinuation of Study or Study Drug Due to Any Reason
The premature discontinuation of study or study drug due to any reason
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
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
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
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
28 weeks (randomisation visit to last follow up visit) according to protocol
Secondary Outcomes (9)
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)
Change in Creatinine Level
4 weeks according to protocol (randomisation visit to week 4 visit)
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)
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)
Plasma Concentration of AZD0837 (Prodrug)
4 weeks after baseline according to protocol
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), \>30 days prior to randomization)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (38)
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
Research Site
Kongsberg, Norway
Research Site
Oslo, Norway
Research Site
Stovner, Norway
Research Site
Straume, Norway
Research Site
Bytom, Poland
Research Site
Częstochowa, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Ostrów Mazowiecka, Poland
Research Site
Otwock, Poland
Research Site
Płock, Poland
Research Site
Ruda Śląska, Poland
Research Site
Sopot, Poland
Research Site
Torun, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
Moscow, Russia
Research Site
Saint Petersburg, Russia
Research Site
Borås, Sweden
Research Site
Gothenburg, Sweden
Research Site
Lund, Sweden
Research Site
Malmo, Sweden
Research Site
Mölndal, Sweden
Research Site
Stockholm, Sweden
Research Site
Birmingham, United Kingdom
Research Site
Eastbourne, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Y Lip, MD
Birmingham City Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 26, 2008
Study Start
October 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 23, 2012
Results First Posted
July 28, 2011
Record last verified: 2012-03