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Completed

NCT Number: NCT00684307

Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.

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Key information

Conditions

NonValvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.
  • Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization)
  • Previous systemic embolism.
  • Symptomatic congestive heart failure (CHF)
  • Impaired left ventricular systolic function
  • Diabetes mellitus
  • Hypertension requiring anti-hypertensive treatment.

Exclusion criteria

  • AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
  • Known contraindication to VKA treatment
  • Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
  • Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization

Treatment and study plan

AZD0837

Drug

ER tablet, PO, once daily for a period of 3-9 months.

Vitamin-K antagonist at INR 2-3

Drug

Tablet, PO for a period of 3-9 months.

Other names: Warfarin

Primary outcomes

  1. Bleeding Events

    Time frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)

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

  2. Creatinine

    Time frame: 12 weeks according to protocol.(baseline to week 12 visit)

    Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)

  3. Alanine Aminotransferase (ALAT)

    Time frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)

    Number of patients while on study drug with ALAT>=3 times upper limit of normal.l

  4. Bilirubin

    Time frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)

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

Secondary outcomes

  1. D-Dimer

    Time frame: 14 weeks according to protocol.(enrolment to week 12 visit)

    Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)

  2. Activated Partial Thromboplastin Time (APTT)

    Time frame: 12 weeks according to protocol.(baseline to week 12 visit)

    Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)

  3. Ecarin Clotting Time (ECT)

    Time frame: 12 weeks according to protocol.(baseline to week 12 visit)

    Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)

  4. Plasma Concentration of AZD0837 (Prodrug)

    Time frame: 12 weeks after baseline according to protocol

    Assessment made on the week 12 visit

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

    Time frame: 12 weeks after baseline according to protocol

    Assessment made on the week 12 visit

  6. Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT

    Time frame: 36 weeks according to protocol

    Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T

  7. Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC

    Time frame: 36 weeks according to protocol

    Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T

  8. Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC

    Time frame: 36 weeks according to protocol

    Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, Given as an Extended-release Formulation, in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 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.

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