CompletedPhase 3

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

Japan74 participantsStarted 2021-03-23

Plain-language summary

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).

Who can participate

Age range20 Years – 85 Years

SexALL

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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

What they're measuring

Ratio of 1-year resting PVR to baseline resting PVR

Timeframe: Week 48 of treatment

Trial details

NCT IDNCT04730037

SponsorKyushu University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-30

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