Phase III Investigator-Initiated Trial to Investigate Safety and Efficacy of Edoxaban in Patients with Chronic Thromboembolic Pulmonary Hypertension

An Investigator-initiated, multicenter, phase 3, randomized, single-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of edoxaban versus warfarin (Vitamin K antagonist) in subjects with chronic thromboembolic pulmonaty hypertension taking warfarin (Vitamin K antagonist) at baseline - KABUKI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071200098

Enrollment

Registered

2021-02-08

Start date

2021-04-09

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension CTEPH, DOAC, warfarin

Interventions

Oral administeration of (1) or (2) (1) Edoxaban group - 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

D000284

Oral administeration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Male and female patients >= 20 or ==25 mmHg and PAWP ==150m

Exclusion criteria

Exclusion criteria: 1)Patients with severe lung disease (FEV1.0/FVC < 60% or %TLC < 60%) 2)Patients with acute or chronic disabilities that interfere with clinical trial requirements 3)Patients with acute symptomatic PE within 180 days prior to the start of study drug administration 4)Patients with congenital heart disease who have not undergone radical surgery 5)Patients who cannot provide informed consent due to mental disorders, dementia, or other illnesses 6)Patients with advanced cancer 7)Patients with a life expectancy of less than 1 year 8)Patients with active hemorrhagic lesions 9)Patients with comorbidities requiring vitamin K antagonist 10)Patients receiving other study drug within 30 days prior to randomization 11)Patients with renal dysfunction (Ccr <15 mL/min) 12)Patients with liver dysfunction (Child-Pugh B or C) 13)Females of reproductive age not using an acceptable form of contraception/Pregnant/Breastfeeding 14)Patients contraindicated for edoxaban or warfarin 15)Patients with hypersensitivity to any of the drug additives 16)Patients judged unsuitable by investigators

Design outcomes

Primary

Measure	Time frame
Ratio of 1-year resting PVR to baseline resting PVR	—

Secondary

Measure	Time frame
Efficacy 1)Percentage of cases with CTEPH exacerbation events 2)Change from baseline in distance of 6-minute walking test (Visit 5, 7, 9) 3)Change from baseline in WHO functional classification class (Visit 5, 7, 9) 4)Change from baseline in NT-proBNP concentration (Visit 5, 7, 9) Safety Percentage of cases with clinically significant bleeding	—

Contacts

Public ContactKazuya Hosokawa

Kyushu University Hospital

hosokawa.kazuya.712@m.kyushu-u.ac.jp+81-92-642-5360

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026