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Completed

NCT Number: NCT04730037

Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)

This is phase III trial to evaluate whether edoxaban, a direct factor Xa inhibitor, is noninferior to warfarin in preventing worsening of chronic thromboembolic pulmonary hypertension (CTEPH).

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Key information

Conditions

CTEPH

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient who once* diagnosed with CTEPH based on at least 2 imaging study (VQ scan, CT pulmonary angiogram, or catheter-based pulmonary angiogram) and hemodynamic criteria (MPAP >=25 mmHg and PAWP =< 15 mmHg). *Patients treated with PEA, BPA, or vasodilators, who do not meet hemodynamic criteria at the registration, are eligible.
  • Patients who are not planned to require increased / changed / discontinuation of PEA, BPA, or pulmonary vasodilators within 12months
  • Stable administration of vitamin K antagonists
  • WHO functional class I-III
  • Patients who meet A) B)and C) by 90 days prior to baseline. A)No addition, reduction, or change of endothelin antagonists, soluble guanylate cyclase stimulants, phosphodiesterase-5 inhibitors, prostacyclin, and its derivatives, or calcium antagonists. B)Appropriate anticoagulants have been continued. C)No BPA has been done.
  • Patients who have not undergone PEA from 180 days prior to baseline right heart catheterization to the start date of study drug administration
  • Patients with a 6-minute walking distance >=150m

Exclusion criteria

  • Patients with severe lung disease (FEV1.0/FVC < 60% or %TLC < 60%)
  • Patients with acute or chronic disabilities that interfere with clinical trial requirements
  • Patients with acute symptomatic PE within 180 days prior to the start of study drug administration
  • Patients with congenital heart disease who have not undergone radical surgery
  • Patients who cannot provide informed consent due to mental disorders, dementia, or other illnesses
  • Patients with advanced cancer
  • Patients with a life expectancy of less than 1 year
  • Patients with active hemorrhagic lesions
  • Patients with comorbidities requiring vitamin K antagonist
  • Patients receiving other study drug within 30 days prior to randomization
  • Patients with renal dysfunction (Ccr 15 mL/min)
  • Patients with liver dysfunction (Child-Pugh B or C)
  • Females of reproductive age not using an acceptable form of contraception/Pregnant/Breastfeeding
  • Patients contraindicated for edoxaban or warfarin
  • Patients with hypersensitivity to any of the drug

Treatment and study plan

Edoxaban

Drug
  • Edoxaban 30 mg/60 mg tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications

Warfarin Potassium

Drug
  • Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5)

Warfarin Potassium placebo

Drug
  • Warfarin K 1 mg placebo tablets once daily

Edoxaban placebo

Drug
  • Edoxaban 30 mg/60 mg placebo tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications

Primary outcomes

  1. Ratio of 1-year resting PVR to baseline resting PVR

    Time frame: Week 48 of treatment

Secondary outcomes

  1. Percentage of cases with worsening of CTEPH

    Time frame: Throughout the study duration(up to week48)

  2. Change from baseline in 6-minute walk distance

    Time frame: Week16, 32, 48 of treatment

  3. Change from baseline in WHO functional class

    Time frame: Week16, 32, 48 of treatment

  4. Change from baseline in NT-proBNP

    Time frame: Week16, 32, 48 of treatment

  5. Percentage of cases with clinically relavant bleeding (ISTH 2015 definition)

    Time frame: Throughout the study duration(up to week48)

Sponsors and collaborators

Lead sponsor

Kyushu University

Other

Collaborators

  • Daiichi Sankyo Co., Ltd.

Registry information

Official study title

An Investigator-initiated, Multicenter, Phase 3, Randomized, Single-blind, Double-dummy, Parallel-group Study of Evaluate the Efficacy and Safety of Edoxaban Versus Warfarin (Vitamin K Antagonist) in Subjects With Chronic Thromboembolic Pulmonary Hypertension Taking Warfarin (Vitamin K Antagonist) at Baseline: KABUKI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2021
Registry last updated
Oct 5, 2023

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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