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Completed

NCT Number: NCT00623779

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

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.

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Key information

Conditions

Persistent or Permanent Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD0837

Drug

ER formulation

Aspirin

Drug

Oral form

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  1. Bleeding Events

    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)

    Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once

  2. Change in Creatinine Level

    Time frame: 4 weeks according to protocol (randomisation visit to week 4 visit)

    Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

  3. Alanine Aminotransferase (ALAT)

    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)

    Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.

  4. Bilirubin

    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)

    Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.

  5. Plasma Concentration of AZD0837 (Prodrug)

    Time frame: 4 weeks after baseline according to protocol

    Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit

  6. Plasma Concentration of AR-H067637XX (Active Metabolite)

    Time frame: 4 weeks after baseline according to protocol

    Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit

  7. Change in D-Dimer Level

    Time frame: 4 weeks according to protocol.(baseline to week 4 visit)

    Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

  8. Activated Partial Thromboplastin Time (APTT)

    Time frame: 4 weeks according to protocol.(baseline to week 4 visit)

    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)

  9. Ecarin Clotting Time (ECT)

    Time frame: 4 weeks according to protocol.(baseline to week 4 visit)

    Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 26, 2008
Registry last updated
Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.