Clinical trial NCT00623779: Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent or Permanent Non-valvular Atrial Fibrillation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Premature Discontinuation of Study or Study Drug Due to Any Reason
timeFrame: 28 week (randomisation visit to last follow up visit in study) according to protocols
measure: Premature Discontinuation of Study Drug Due to Any Reason
timeFrame: 24 weeks (randomisation visit to last treatment visit)
measure: Premature Discontinuation of Study Due to Any Reason
timeFrame: 28 weeks (randomisation visit to last follow up visit)
measure: Compliance With Study Drug
timeFrame: 24 weeks (randomisation visit to last treatment visit) according to protocol
measure: Compliance With Study Visits/Assessments
timeFrame: 28 weeks (randomisation visit to last follow up visit) according to protocol
Secondary outcomes:
measure: Bleeding Events
timeFrame: 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)
measure: Change in Creatinine Level
timeFrame: 4 weeks according to protocol (randomisation visit to week 4 visit)
measure: Alanine Aminotransferase (ALAT)
timeFrame: 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)
measure: Bilirubin
timeFrame: 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)
measure: Plasma Concentration of AZD0837 (Prodrug)
timeFrame: 4 weeks after baseline according to protocol
measure: Plasma Concentration of AR-H067637XX (Active Metabolite)
timeFrame: 4 weeks after baseline according to protocol
measure: Change in D-Dimer Level
timeFrame: 4 weeks according to protocol.(baseline to week 4 visit)
measure: Activated Partial Thromboplastin Time (APTT)
timeFrame: 4 weeks according to protocol.(baseline to week 4 visit)
measure: Ecarin Clotting Time (ECT)
timeFrame: 4 weeks according to protocol.(baseline to week 4 visit)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Site
city: Arhus N
country: Denmark
facility: Research Site
city: Copenhagen
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Frederikssund
country: Denmark
facility: Research Site
city: Horsens
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
city: Silkeborg
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Gjettum
country: Norway
facility: Research Site
city: Kongsberg
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Stovner
country: Norway
facility: Research Site
city: Straume
country: Norway
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Czestochowa
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostrow Mazowiecka
country: Poland
facility: Research Site
city: Otwock
country: Poland
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Boras
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Molndal
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Eastbourne
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Birmingham City Hospital
name: Gregory Y Lip, MD
role: PRINCIPAL_INVESTIGATOR
References: