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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04730037
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kyushu University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kohtaro Abe
Principal Investigator Affiliation	Kyushu University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Active, not recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	CTEPH

Arms & Interventions

Arms

Active Comparator: Edoxaban group

Active Comparator: Warfarin group

Interventions

Drug: - Edoxaban

- Edoxaban 30 mg/60 mg tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications

Drug: - Warfarin Potassium

- Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5)

Drug: - Warfarin Potassium placebo

- Warfarin K 1 mg placebo tablets once daily

Drug: - Edoxaban placebo

- Edoxaban 30 mg/60 mg placebo tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kyushu University Hospital, Fukuoka, Japan

Status

Address

Kyushu University Hospital

Fukuoka, , 812-8582

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