Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study

Summary

The purpose of this study is to determine the optimal duration of anticoagulation therapy (3 months versus 12 months) with direct oral anticoagulant (edoxaban) for isolated distal deep vein thrombosis.

Timeline

Start

2019-05-27

Primary completion

2023-06-30

Completion

2023-08-31

Outcome

Met primary endpoint

paper 12 months was superior to 3 months for an edoxaban treatment with respect to the composite outcome of a symptomatic recurrent VTE or VTE-related death. PMID 37638968 ↗

Publications

• Nishikawa T, Yamashita Y, Fujita M, Morimoto T, Muraoka N, Umetsu M, Nishimoto Y, Takada T, Ogihara Y, Ikeda N, Otsui K, Sueta D, Tsubata Y, Shoji M, Shikama A, Hosoi Y, Tanabe Y, Chatani R, Tsukahara K, Nakanishi N, Kim K, Ikeda S, Yasui T, Yamamoto H, Ono K, Kimura T; ONCO DVT Study Investigators. D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis. Blood Vessel Thromb Hemost. 2025 Feb 24;2(2):100063. doi: 10.1016/j.bvth.2025.100063. eCollection 2025 May.
• Chatani R, Yamashita Y, Morimoto T, Muraoka N, Umetsu M, Nishimoto Y, Takada T, Ogihara Y, Nishikawa T, Ikeda N, Otsui K, Sueta D, Tsubata Y, Shoji M, Shikama A, Hosoi Y, Tanabe Y, Tsukahara K, Nakanishi N, Kim K, Ikeda S, Mushiake K, Kadota K, Ono K, Kimura T. Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO DVT study. Eur Heart J Cardiovasc Pharmacother. 2024 Aug 14;10(5):422-431. doi: 10.1093/ehjcvp/pvae028.
• Yamashita Y, Morimoto T, Muraoka N, Oyakawa T, Umetsu M, Akamatsu D, Nishimoto Y, Sato Y, Takada T, Jujo K, Minami Y, Ogihara Y, Dohi K, Fujita M, Nishikawa T, Ikeda N, Hashimoto G, Otsui K, Mori K, Sueta D, Tsubata Y, Shoji M, Shikama A, Hosoi Y, Tanabe Y, Chatani R, Tsukahara K, Nakanishi N, Kim K, Ikeda S, Mo M, Yoshikawa Y, Kimura T; ONCO DVT Study Investigators. Edoxaban for 12 Months Versus 3 Months in Patients With Cancer With Isolated Distal Deep Vein Thrombosis (ONCO DVT Study): An Open-Label, Multicenter, Randomized Clinical Trial. Circulation. 2023 Nov 21;148(21):1665-1676. doi: 10.1161/CIRCULATIONAHA.123.066360. Epub 2023 Aug 28.

Drugs

Indications