Overview

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

Status:
Recruiting

Trial end date:
2023-07-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kyushu University

Collaborator:

Daiichi Sankyo Co., Ltd.

Treatments:

Edoxaban
Warfarin

Criteria

Inclusion Criteria:

1. 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.

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

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