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

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

Tracking Information

• First Submitted Date: March 27, 2019
• First Posted Date: March 29, 2019
• Last Update Posted Date: October 4, 2023
• Actual Study Start Date: May 27, 2019
• Actual Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2019)

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.)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 28, 2019)

• 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.
• All-cause death [ Time Frame: 12 months ]
• 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.
• 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.)
• 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.
• Clinically relevant bleeding [ Time Frame: 12 months ]
  Clinically relevant bleeding is defined as major or CRNM bleeding.
• 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.
• 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.
• 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.
• Change of serum D-dimer levels during follow-up period [ Time Frame: 12 months ]
• Any adverse outcomes during invasive procedures [ Time Frame: 12 months ]
  Adverse outcomes include bleeding events, recurrent VTE events, all-cause deaths.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
• Official Title: Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
• 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.
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Venous Thrombosis
• Neoplasms
• Anticoagulant

Intervention

• Drug: 12-month Edoxaban
  Prescription of Edoxaban for 12 months
• Drug: 3-month Edoxaban
  Prescription of Edoxaban for 3 months

Study Arms

• Experimental: 12-month Edoxaban
  Edoxaban for 12 months
  Intervention: Drug: 12-month Edoxaban
• Active Comparator: 3-month Edoxaban
  Edoxaban for 3 months
  Intervention: Drug: 3-month Edoxaban

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2022): 605
• Original Estimated Enrollment (submitted: March 28, 2019): 600
• Actual Study Completion Date: August 31, 2023
• Actual Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT03895502
• Other Study ID Numbers: Y0019
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Takeshi Morimoto, Kyoto University, Graduate School of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Takeshi Morimoto
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Takeshi Kimura, MD, PhD; Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

• PRS Account: Kyoto University, Graduate School of Medicine
• Verification Date: October 2023