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

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ClinicalTrials.gov Identifier: NCT03895502
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : October 4, 2023
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Neoplasms Anticoagulant Drug: 12-month Edoxaban Drug: 3-month Edoxaban Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
Actual Study Start Date : May 27, 2019
Actual Primary Completion Date : June 30, 2023
Actual Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: 12-month Edoxaban
Edoxaban for 12 months
 Drug: 12-month Edoxaban
Prescription of Edoxaban for 12 months
Active Comparator: 3-month Edoxaban
Edoxaban for 3 months
 Drug: 3-month Edoxaban
Prescription of Edoxaban for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Symptomatic VTE recurrence event or VTE related death event [ Time Frame: 12 months ]
    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.)


Secondary Outcome Measures :
  1. Major bleeding event (ISTH criteria) [ Time Frame: 12 months ]
    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.

  2. All-cause death [ Time Frame: 12 months ]
  3. Symptomatic VTE recurrence event [ Time Frame: 12 months ]
    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.

  4. VTE related death event [ Time Frame: 12 months ]
    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.)

  5. Clinically relevant non-major (CRNM) bleeding [ Time Frame: 12 months ]
    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.

  6. Clinically relevant bleeding [ Time Frame: 12 months ]
    Clinically relevant bleeding is defined as major or CRNM bleeding.

  7. Bleeding related death event [ Time Frame: 12 months ]
    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.

  8. Unsuspected recurrent DVT by follow-up ultrasound examinations [ Time Frame: 12 months ]
    Unsuspected DVT by follow-up ultrasound examinations is a thrombus that is detected during follow-up ultrasound testing without suspicion of DVT.

  9. Unsuspected recurrent VTE by any imaging examinations [ Time Frame: 12 months ]
    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.

  10. Change of serum D-dimer levels during follow-up period [ Time Frame: 12 months ]
  11. Any adverse outcomes during invasive procedures [ Time Frame: 12 months ]
    Adverse outcomes include bleeding events, recurrent VTE events, all-cause deaths.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895502


Locations
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Japan
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Takeshi Morimoto
Investigators
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Study Chair: Takeshi Kimura, MD, PhD Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
More Information
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Responsible Party: Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT03895502    
Other Study ID Numbers: Y0019
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
Venous Thrombosis
Neoplasms
Anticoagulant
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Edoxaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants