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Venous ThrombosisPhase 4ONCO DVTNCT03895502

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

A Phase 4 study testing 12-month Edoxaban and 3-month Edoxaban in people with Venous Thrombosis and Neoplasms, run by Takeshi Morimoto at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Venous Thrombosis, Neoplasms, Anticoagulant
What is being tested?
12-month Edoxaban and 3-month Edoxaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
1 siteJapan
Study dates
27 May 2019to 31 Aug 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly found isolated distal deep vein thrombosis
  • Patients complicated with active cancer
  • Patients who are scheduled to be treated by anticoagulation therapy.

Who cannot join

  • Patients with anticoagulation therapy for the index event before 10 days of allocation.
  • Patient under anticoagulation therapy for the purpose of other than the index event.
  • Patients with thrombolysis therapy or IVC filter at the Index event.
  • Patients with creatinine clearance less than 30 ml/min.
  • Patients who are expected to have a life prognosis of 3 months or less.
  • Patients with pulmonary embolism.
  • Patients who are not appropriate for the participation of the study.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

    Kyoto, 606-8507

Other trials in Japan

About this study

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.

Read the detailed description

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).

Being tested
12-month Edoxaban, 3-month Edoxaban
Keywords
Venous Thrombosis, Neoplasms, Anticoagulant
Medical subject headings
Venous Thrombosis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12-month EdoxabanDrug

    Prescription of Edoxaban for 12 months

  • 3-month EdoxabanDrug

    Prescription of Edoxaban for 3 months

Study groups in NCT03895502
Study groupRoleWhat they receive
12-month EdoxabanExperimentalEdoxaban for 12 months
Receives: Drug: 12-month Edoxaban
3-month EdoxabanActive comparatorEdoxaban for 3 months
Receives: Drug: 3-month Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: 12 months

Secondary outcomes (11)

  1. 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.

    Measured: 12 months

  2. All-cause death

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.)

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. Clinically relevant bleeding

    Clinically relevant bleeding is defined as major or CRNM bleeding.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: 12 months

  10. Change of serum D-dimer levels during follow-up period

    Measured: 12 months

  11. Any adverse outcomes during invasive procedures

    Adverse outcomes include bleeding events, recurrent VTE events, all-cause deaths.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start27 May 2019
  3. Primary completion30 Jun 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895502
Sponsor's protocol ID
Y0019
Acronym
ONCO DVT
Status last verified
Oct 2023
First submitted
27 Mar 2019
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 40766276

  • 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.

    PubMed 38650055

  • 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.

    PubMed 37638968

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 12-month Edoxaban and 3-month Edoxaban in people with Venous Thrombosis and Neoplasms, run by Takeshi Morimoto at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic VTE recurrence event or VTE related death event (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03895502, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.

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