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OpenTrials
Completed

NCT Number: NCT00645853

Long-term Safety in Atrial Fibrillation Patients

The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).

Completed

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Key information

Conditions

Persistent or Permanent 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

  • Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
  • completing treatment with study drug in D1250C00008.

Exclusion criteria

  • Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
  • Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment
  • Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
  • Conditions associated with increased risk of major bleeding.

Treatment and study plan

AZD0837

Drug

Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od

VKA INR 2-3

Drug

Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Other names: warfarin

Primary outcomes

  1. Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period

    Time frame: 154-711 days on treatment

    Participants

Secondary outcomes

  1. Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline

    Time frame: From baseline to Follow up

    ULN=Upper limit of Normal

  2. Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline

    Time frame: From baseline to Follow up

  3. Creatinine: Absolute Change From Baseline, at End of Treatment

    Time frame: Baseline and End of treatment

  4. D-dimer:Median and Quartile Range at End of Treatment

    Time frame: End of treatment

    Median (Lower Quartile-Upper Quartile ), ng/mL

  5. Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment

    Time frame: Baseline and End of treatment

    Median Full range, Seconds

  6. Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment

    Time frame: Baseline and End of Treatment

  7. AZD0837: Plasma Concentration of AZD0837 at End of Treatment

    Time frame: End of treatment

  8. AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment

    Time frame: 154-711 days on treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Long-term Treatment With the Oral Direct Thrombin Inhibitor AZD0837, Compared to Vitamin-K Antagonists, as Stroke Prevention in Patients With Non-valvular Atrial Fibrillation and One or More Risk Factors for Stroke and Systemic Embolic Events. A 5-year Follow-up Study

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 28, 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.