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Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)

Primary Purpose

Persistent or Permanent Non-valvular Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD0837
Aspirin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Persistent or Permanent Non-valvular Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

Premature Discontinuation of Study or Study Drug Due to Any Reason
The premature discontinuation of study or study drug due to any reason
Premature Discontinuation of Study Drug Due to Any Reason
The premature discontinuation of study drug due to any reason
Premature Discontinuation of Study Due to Any Reason
|The premature discontinuation of study due to any reason
Compliance With Study Drug
[(number of doses dispensed-number of doses returned)/number of days between visits]*100
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

Secondary Outcome Measures

Bleeding Events
Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once
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)
Alanine Aminotransferase (ALAT)
Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.
Bilirubin
Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.
Plasma Concentration of AZD0837 (Prodrug)
Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
Plasma Concentration of AR-H067637XX (Active Metabolite)
Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
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)
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)
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)

Full Information

First Posted
February 15, 2008
Last Updated
March 20, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00623779
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent or Permanent Non-valvular Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AZD0837
Intervention Description
ER formulation
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Oral form
Primary Outcome Measure Information:
Title
Premature Discontinuation of Study or Study Drug Due to Any Reason
Description
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
Title
Premature Discontinuation of Study Drug Due to Any Reason
Description
The premature discontinuation of study drug due to any reason
Time Frame
24 weeks (randomisation visit to last treatment visit)
Title
Premature Discontinuation of Study Due to Any Reason
Description
|The premature discontinuation of study due to any reason
Time Frame
28 weeks (randomisation visit to last follow up visit)
Title
Compliance With Study Drug
Description
[(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
Title
Compliance With Study Visits/Assessments
Description
(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
Secondary Outcome Measure Information:
Title
Bleeding Events
Description
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)
Title
Change in Creatinine Level
Description
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)
Title
Alanine Aminotransferase (ALAT)
Description
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)
Title
Bilirubin
Description
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)
Title
Plasma Concentration of AZD0837 (Prodrug)
Description
Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
Time Frame
4 weeks after baseline according to protocol
Title
Plasma Concentration of AR-H067637XX (Active Metabolite)
Description
Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
Time Frame
4 weeks after baseline according to protocol
Title
Change in D-Dimer Level
Description
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)
Title
Activated Partial Thromboplastin Time (APTT)
Description
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)
Title
Ecarin Clotting Time (ECT)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Y Lip, MD
Organizational Affiliation
Birmingham City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Arhus N
Country
Denmark
Facility Name
Research Site
City
Copenhagen
Country
Denmark
Facility Name
Research Site
City
Esbjerg
Country
Denmark
Facility Name
Research Site
City
Frederikssund
Country
Denmark
Facility Name
Research Site
City
Horsens
Country
Denmark
Facility Name
Research Site
City
Kobenhavn
Country
Denmark
Facility Name
Research Site
City
Silkeborg
Country
Denmark
Facility Name
Research Site
City
Svendborg
Country
Denmark
Facility Name
Research Site
City
Elverum
Country
Norway
Facility Name
Research Site
City
Gjettum
Country
Norway
Facility Name
Research Site
City
Kongsberg
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Stovner
Country
Norway
Facility Name
Research Site
City
Straume
Country
Norway
Facility Name
Research Site
City
Bytom
Country
Poland
Facility Name
Research Site
City
Czestochowa
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Ostrow Mazowiecka
Country
Poland
Facility Name
Research Site
City
Otwock
Country
Poland
Facility Name
Research Site
City
Plock
Country
Poland
Facility Name
Research Site
City
Ruda Slaska
Country
Poland
Facility Name
Research Site
City
Sopot
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Boras
Country
Sweden
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Molndal
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Eastbourne
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

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Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)

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