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

Abe Kohtaro0 个研究点目标入组 74 人开始时间: 2021年2月8日最近更新: 2023年10月17日

研究概览

暂无简介。

•1)Male and female patients >= 20 or =< 85 years of age
•2)Patient who once* diagnosed with CTEPH based on imaging study (VQ scan, CT 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.
•3)Patients who are not planned to require increased / changed / discontinuation of PEA, BPA, or pulmonary vasodilators within 12 months
•4)Stable administration of vitamin K antagonists
•5)WHO functional class I-III
•6)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, prostacyclin agonist, or calcium antagonists
•B)Appropriate anticoagulants have been continued
•C)No BPA has been done
•7)Patients who have not undergone PEA from 180 days prior to baseline right heart catheterization to the start date of study drug administration
•8)Patients with a 6-minute walking distance >=150m

•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

发起方

Abe Kohtaro