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Completed

NCT Number: NCT02964949

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber.

Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete.

Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

O L V Ziekenhuis, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meets protocol-specified criteria for qualification
  • Is able to follow the protocol specified contraception methods
  • Is willing and able to comply with any restrictions related to food, drink and medications
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion criteria

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Treatment and study plan

Edoxaban

Drug

Edoxaban will be provided in blister packs with active and placebo tablets maintaining the blind, i.e., one 60 mg active tablet and a 15 mg placebo or one 60 mg active tablet and a 15 mg active tablet. Transition doses of 30 mg + 15 mg edoxaban are provided in 14-tablet blister packs.

Primary outcomes

  1. Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)

    Time frame: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)

    In pharmacokinetics, steady state means the overall intake of a drug is about equal to its elimination

  2. Pharmacokinetics: Minimum Concentration of Edoxaban in Plasma (Cmin)

    Time frame: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)

    Cmin is a term used in pharmacokinetics that usually refers to the minimum blood plasma concentration that a drug achieves after the drug has been administered and prior to the administration of a second dose

  3. Pharmacodynamics: Mean exposure using validated assays

    Time frame: Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)

    Exposure analysis performed with validated Liquid Chromatography/Tandem Mass Spectrometry/Mass Spectrometry (LC/MS/MS) assay with lithium heparin plasma.

    Categories: Edoxaban and its metabolite (D21-2393)

  4. Pharmacodynamics: Mean exposure with anti-Factor Xa (FXa) assay

    Time frame: Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)

    Exposure analysis performed with anti-FXa assay, using sodium citrate plasma samples Categories: Edoxaban and D21-2393

Secondary outcomes

  1. Efficacy: Number of participants with composite event 1

    Time frame: within 3 years

    Composite event 1 includes ischemic or hemorrhagic stroke/transient ischemic attack (TIA) and systemic embolic events (SEE)

  2. Efficacy: Number of participants with composite event 2

    Time frame: within 3 years

    Composite event 2 includes stroke/TIA, SEE, myocardial infarction, cardiovascular death, and major bleeding

  3. Safety: Number of participants with major bleeding (including intracranial)

    Time frame: within 3 years

    Major bleeding is defined per the International Society on Thrombosis and Haemostasis (ISTH) definition

  4. Safety: Number of participants with clinically relevant bleeding

    Time frame: within 3 years

    Clinically relevant bleeding is a combination of major bleeding and clinically relevant non-major (CRNM) bleeding

  5. Safety: Number of participants with any bleeding

    Time frame: within 3 years

    Count of participants who experienced any bleeding event

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

Evaluation of Edoxaban in Anticoagulant Naïve Patients With Nonvalvular Atrial Fibrillation (NVAF) and High Creatinine Clearance

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2016
Registry last updated
Feb 12, 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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