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

Phase 3

Completed

• Conditions: CTEPH
• Interventions: Drug: Edoxaban; Drug: Warfarin Potassium; Drug: Warfarin Potassium placebo; Drug: Edoxaban placebo

• Registration Number: NCT04730037
• Lead Sponsor: Kyushu University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-29
• Study Start: 2021-03-23
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. 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.
2. Patients who are not planned to require increased / changed / discontinuation of PEA, BPA, or pulmonary vasodilators within 12months
3. Stable administration of vitamin K antagonists
4. WHO functional class I-III
5. 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.
6. Patients who have not undergone PEA from 180 days prior to baseline right heart catheterization to the start date of study drug administration
7. Patients with a 6-minute walking distance >=150m

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edoxaban group	Warfarin Potassium placebo	-
Edoxaban group	Edoxaban	-
Warfarin group	Warfarin Potassium	-
Warfarin group	Edoxaban placebo	-

Primary Outcome Measures

Name	Time	Method
Ratio of 1-year resting PVR to baseline resting PVR	Week 48 of treatment

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan