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Completed

NCT Number: NCT00504556

A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Minsk, Belarus

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, 18 to 80 years old.
  • Able to provide written informed consent.
  • Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
  • A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2

Exclusion criteria

  • Subjects with mitral valve disease or previous valvular heart surgery
  • Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
  • Known or suspected hereditary or acquired bleeding or coagulation disorder

Treatment and study plan

Edoxaban (DU-176b)

Drug

30mg tablet once daily

Warfarin

Drug

warfarin tablets

Primary outcomes

  1. Adjudicated Incidence of Bleeding Events

    Time frame: 3 months

    Adjudicated Incidence of Bleeding Events during treatment period

  2. Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)

    Time frame: 3 months

    liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities

Secondary outcomes

  1. Incidence of Major Adverse Cardiac Events MACE)

    Time frame: 3 months

    MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition

  2. Effects on Biomarker D-dimer

    Time frame: 3 months

    Mean (SD) change from baseline in D-dimer

  3. Effects on Biomarker Prothrombin Fragments

    Time frame: 3 months

    Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)

  4. Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b

    Time frame: 3 months

    Median (min, max) values of Cmin,ss; Cmax,ss

  5. Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b

    Time frame: 3 months

    Median (min, max) values of AUCss

  6. Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b

    Time frame: Day 28

    Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.

  7. Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b

    Time frame: Day 28

    Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.

  8. Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b

    Time frame: Day 28

    Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose.

    PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition.

  9. Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b

    Time frame: Day 28

    Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.

  10. Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b

    Time frame: Day 28

    Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 20, 2007
Registry last updated
Feb 26, 2019

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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