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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.
Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating PE and/or proximal DVT, although data on isolated distal DVT (IDDVT) has been quite limited. However, IDDVT was reported to account for about half of all the diagnoses of DVT detected on ultrasound in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines suggest the same approach for IDDVT patients with cancer as proximal DVT patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that IDDVT patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, we will randomly assign IDDVT patients with active cancer to receive either edoxaban for 3 months (short DOAC group) or edoxaban for 12 months (long DOAC group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-month Edoxaban | Experimental | Edoxaban for 12 months |
|
| 3-month Edoxaban | Active Comparator | Edoxaban for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-month Edoxaban | Drug | Prescription of Edoxaban for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic VTE recurrence event or VTE related death event | Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. VTE related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer.) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding event (ISTH criteria) | Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Kimura, MD, PhD | Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40766276 | Derived | 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. | |
| 38650055 |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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| 3-month Edoxaban |
| Drug |
Prescription of Edoxaban for 3 months |
|
| All-cause death |
| 12 months |
| Symptomatic VTE recurrence event | Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. | 12 months |
| VTE related death event | VTE related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer.) | 12 months |
| Clinically relevant non-major (CRNM) bleeding | A bleeding event will be classified as a clinically relevant non-major bleeding event if it is overt (i.e. is symptomatic or visualized by examination) not meeting the criteria for major bleeding, requires medical attention or is associated with discomfort for the subject such as pain, or impairment of activities of daily life. | 12 months |
| Clinically relevant bleeding | Clinically relevant bleeding is defined as major or CRNM bleeding. | 12 months |
| Bleeding related death event | Bleeding related death event is defined as a bleeding event directly led to death. Examples of fatal bleeding events are an intracranial hemorrhage that led to herniation of the brain and death within 24 hours, and a massive gastrointestinal hemorrhage that results in shock, hemodynamic collapse, and death. | 12 months |
| Unsuspected recurrent DVT by follow-up ultrasound examinations | Unsuspected DVT by follow-up ultrasound examinations is a thrombus that is detected during follow-up ultrasound testing without suspicion of DVT. | 12 months |
| Unsuspected recurrent VTE by any imaging examinations | Unsuspected recurrent VTE is defined as thrombi that are detected during imaging testing performed for other reasons (e.g., computed tomography (CT) for cancer staging) and not for suspicion of DVT or PE. | 12 months |
| Change of serum D-dimer levels during follow-up period | 12 months |
| Any adverse outcomes during invasive procedures | Adverse outcomes include bleeding events, recurrent VTE events, all-cause deaths. | 12 months |
| Derived |
| 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. |
| 37638968 | Derived | 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. |