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

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).

Timeline

Start

2021-03-23

Primary completion

2023-03-30

Completion

2023-06-27

Publications

• Background Hosokawa K, Abe K, Tsutsui H. Use of direct oral anticoagulants prevents increase in pulmonary vascular resistance and incidence of clinical worsening in patients with chronic thromboembolic pulmonary hypertension. Thromb Res. 2019 Aug;180:43-46. doi: 10.1016/j.thromres.2019.05.018. Epub 2019 May 31. No abstract available.
• Hosokawa K, Abe K, Kishimoto J, Kobayakawa Y, Todaka K, Tamura Y, Tatsumi K, Inami T, Ikeda N, Taniguchi Y, Minatsuki S, Murohara T, Yasuda S, Fukuda K, Tsutsui H. Efficacy and safety of edoxaban in patients with chronic thromboembolic pulmonary hypertension: protocol for a multicentre, randomised, warfarin-controlled, parallel group trial - KABUKI trial. BMJ Open. 2022 Jul 19;12(7):e061225. doi: 10.1136/bmjopen-2022-061225.

Drugs

Indications