NCT04730037已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Ratio of 1-year resting PVR to baseline resting PVR
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Edoxaban group
Active Comparator
干预措施: Edoxaban (Drug)
Edoxaban group
Active Comparator
干预措施: Warfarin Potassium placebo (Drug)
Warfarin group
Active Comparator
干预措施: Warfarin Potassium (Drug)
Warfarin group
Active Comparator
干预措施: Edoxaban placebo (Drug)
结局指标
主要结局
Ratio of 1-year resting PVR to baseline resting PVR
时间窗: Week 48 of treatment
次要结局
- Percentage of cases with worsening of CTEPH(Throughout the study duration(up to week48))
- Change from baseline in 6-minute walk distance(Week16, 32, 48 of treatment)
- Change from baseline in WHO functional class(Week16, 32, 48 of treatment)
- Change from baseline in NT-proBNP(Week16, 32, 48 of treatment)
- Percentage of cases with clinically relavant bleeding (ISTH 2015 definition)(Throughout the study duration(up to week48))
研究者
Kohtaro Abe
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Kyushu University
研究点 (1)
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