Status:
COMPLETED
Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)
Lead Sponsor:
Kyushu University
Collaborating Sponsors:
Daiichi Sankyo Co., Ltd.
Conditions:
CTEPH
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04730037
Start Date
March 23 2021
End Date
June 27 2023
Last Update
October 5 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kyushu University Hospital
Fukuoka, Japan, 812-8582