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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
\- 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
\- Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5)
\- Warfarin K 1 mg placebo tablets once daily
Kyushu University Hospital
Fukuoka, Japan
Ratio of 1-year resting PVR to baseline resting PVR
Time frame: Week 48 of treatment
Percentage of cases with worsening of CTEPH
Time frame: Throughout the study duration(up to week48)
Change from baseline in 6-minute walk distance
Time frame: Week16, 32, 48 of treatment
Change from baseline in WHO functional class
Time frame: Week16, 32, 48 of treatment
Change from baseline in NT-proBNP
Time frame: Week16, 32, 48 of treatment
Percentage of cases with clinically relavant bleeding (ISTH 2015 definition)
Time frame: Throughout the study duration(up to week48)
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\- 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