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NCT03895502: ONCO DVT
Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
Phase 4 trial testing 12-month Edoxaban in Venous Thrombosis in 605 participants. Completed in 31 August 2023.
30 June 2023
Quick facts
| Lead sponsor | Takeshi Morimoto |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 605 |
| Start date | 27 May 2019 |
| Primary completion | 30 June 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- 12-month Edoxaban — full drug profile →
- 3-month Edoxaban — full drug profile →
Conditions studied
- Venous Thrombosis — all drugs for Venous Thrombosis →
- Neoplasms — all drugs for Neoplasms →
- Anticoagulant — all drugs for Anticoagulant →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03895502
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Venous Thrombosis
Currently open trials in the same condition.
- NCT06672250 — The Correlation Between Circulatory Tumor Cells and Venous Thrombosis · recruiting
- NCT04649489 — A Study to Evaluate Efficacy and Safety of Hepatic Resection for Liver Cancer With PVTT, HVTT or IVCTT After Initial Ate · Phase 3 · active not recruiting
Other Takeshi Morimoto trials
Trials by the same sponsor.
- NCT04724460 — Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer · Phase 4 · completed
- NCT04691700 — GOREISAN for Heart Failure (GOREISAN-HF) Trial · Phase 4 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03895502 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeshi Morimoto
- Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03895502.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing