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NCT03895502: ONCO DVT

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

Completed Phase 4 Last updated 4 October 2023
What this trial tests

Phase 4 trial testing 12-month Edoxaban in Venous Thrombosis in 605 participants. Completed in 31 August 2023.

Timeline
27 May 2019
Primary endpoint
30 June 2023
31 August 2023

Quick facts

Lead sponsorTakeshi Morimoto
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment605
Start date27 May 2019
Primary completion30 June 2023
Estimated completion31 August 2023
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Takeshi Morimoto — full company profile →

Who can join

20 and older, any sex, with Venous Thrombosis or Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Yamashita Y, Morimoto T, Muraoka N, Oyakawa T, et al · · 2023 · cited 41× · PMID 37638968 · DOI 10.1161/circulationaha.123.066360
  2. Spontaneous Hemorrhagic Pericardial and Pleural Effusion in a Patient Receiving Apixaban.
    Cinelli M, Uddin A, Duka I, Soomro A, et al · · 2019 · cited 13× · PMID 31413784 · DOI 10.14740/cr902
  3. Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO DVT study.
    Chatani R, Yamashita Y, Morimoto T, Muraoka N, et al · · 2024 · cited 5× · PMID 38650055 · DOI 10.1093/ehjcvp/pvae028
  4. Clinical outcomes of cancer-associated isolated distal deep vein thrombosis: a comparison between asymptomatic and symptomatic thrombosis-findings from the ONCO DVT Study.
    Ogihara Y, Yamashita Y, Morimoto T, Muraoka N, et al · · 2025 · cited 2× · PMID 40224278 · DOI 10.1016/j.rpth.2025.102722
  5. What's new in the prevention and treatment of cancer-associated thrombosis?
    Kimpton M, Carrier M. · · 2019 · cited 2× · PMID 31808858 · DOI 10.1182/hematology.2019000023
  6. Net Clinical Benefit of 12-Month Over 3-Month Edoxaban in Cancer-Associated Isolated Distal Deep Vein Thrombosis.
    Nishimoto Y, Yamashita Y, Morimoto T, Muraoka N, et al · · 2024 · cited 1× · PMID 39801633 · DOI 10.1016/j.jaccao.2024.07.019
  7. D-dimer after 3 months of anticoagulation therapy and outcomes in cancer-associated isolated distal deep vein thrombosis.
    Nishikawa T, Yamashita Y, Fujita M, Morimoto T, et al · · 2025 · PMID 40766276 · DOI 10.1016/j.bvth.2025.100063
  8. Net Clinical Benefit of Edoxaban for 12 versus 3 Months in Cancer-associated Isolated Distal Deep Vein Thrombosis: ONCO DVT study
    Nishimoto Y, Yamashita Y, Morimoto T, Muraoka N, et al · · 2024 · DOI 10.1101/2024.02.27.24303473

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